Isabella Ciccone, MPH

Fast, accurate diagnosis of multiple sclerosis (MS) can be life-changing for patients, and new updates to the existing criteria are aiming to make that possible, ensuring that those living with the condition get the treatment they need when it matters most. Building on decades of research and clinical experience, the McDonald diagnostic criteria have served as a cornerstone in diagnosing MS, evolving over the years to keep up with the advancements occurring in the field. First established in 2001

, the criteria aim to balance sensitivity and specificity in identifying MS.

Since 2021, a panel of experts has been refining the guidelines to integrate cutting-edge insights into the disease’s biological mechanisms. This latest update prioritizes earlier and more accurate diagnoses by incorporating advanced imaging and biomarker tools alongside clinical evaluations, enabling timely treatment and improved outcomes for patients. Earlier this year, at the 

2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, held September 18-20 in Copenhagen, Denmark

, unveiled these newly updated criteria during a scientific session cochaired by 

Overall, these revisions included the adoption of advanced diagnostic methods and the development of age-specific criteria to more accurately diagnose MS in both younger and older populations. The aim of these changes is to enhance diagnostic precision by examining biomarkers of MS-related damage that go beyond observable symptoms. The finalized guidelines are expected to be published in a peer-reviewed journal by early 2025, although delays in the review process are possible. Once released, organizations like the 

 and ECTRIMS plan to educate providers and patients, ensuring that clinicians effectively implement the updates into their practice.

Voices of clinicians featured in recent conversations with 

 offer a collective and valuable perspective on how the updated McDonald criteria will influence MS diagnosis in clinical practice. Each of the insights from the experts bridge the gap between the progress made in cutting-edge research and the experiences of day-to-day patient care. As part of 

 series, these clinical views expand the conversation surrounding the new criteria beyond the guidelines themselves, highlighting their practical implications for improving outcomes in MS management overall.

Proposed New Guidelines for Diagnosing MS

"During my presentation, I realized that while they may look quite complex, they are not so. Again, I want to highlight that the criteria are very much evidence based. I think this is the first time the entire set of criteria is truly evidence-based—they are sensible, logical, and the diagnostic algorithm is very easy to follow,” Montalban, chair of neurology at Hospital Universitari Vall d’Hebron, told 

 in a recent interview. As highlighted by Montalban, the proposed new revisions to the MS diagnostic criteria aim to improve accuracy and consistency in diagnosis.

Key changes in the new criteria presented at ECTRIMS 2024 included recognizing radiologically isolated syndrome (RIS) as MS in specific cases, adding the optic nerve as a fifth anatomical location, and removing the requirement for dissemination in time (DIT). Updates to dissemination in space criteria were introduced alongside the inclusion of kappa free light chains as a diagnostic tool. Montalban also highlighted in the presentation that the same criteria can be applied to both primary progressive MS and relapsing-remitting MS, with stricter standards for diagnosing older patients or those with comorbidities like migraine or vascular disorders.

“I view this as a significant shift in how we diagnose MS, primarily because we no longer require a clinical syndrome, such as a relapse or progression. So, we’ll be diagnosing MS in patients with atypical symptoms or even no symptoms,” said 

, consultant neurologist at Queen's Square MS Center in London, told 

. “It's going to be an interesting time ahead.”

Additional key changes featured in the presented criteria included the recommendation of optional tools, such as the central vein sign (CVS) and paramagnetic rim lesions (PRLs), for specific cases, and myelin oligodendrocyte glycoprotein antibody tests suggested for diagnosing children and adolescents. During the presentation, Montalban emphasized using paraclinical evidence for the confirmation of MS diagnoses across different patient populations. According to the clinicians 

 spoke with, these revisions may reflect a more nuanced approach to MS diagnosis, accommodating a broader range of clinical presentations.

Calabresi, codirector of the Precision Medicine MS Center at Johns Hopkins University, shared with 

that incorporating the optic nerve as a "fifth topology" or classic location represents a significant change in the diagnostic criteria for MS. While optic neuropathy or optic neuritis has long been recognized as a common MS manifestation, it was not previously included in the criteria.

"I think adding that will be useful," he said. He also highlighted the integration of newer imaging technologies, such as optical coherence tomography (OCT), which can now assess inter-eye differences. Specifically, an inter-eye difference of more than 6 microns in the retinal nerve fiber layer or 4 microns in the ganglion cell inner plexiform complex could help confirm a diagnosis of optic neuropathy.

Joseph Kuchling, MD, a postdoctoral research assistant at Charité University Berlin, also highlighted an important update to the diagnostic criteria: the inclusion of specific markers like the CVS and PRLs. "These additions could help improve the specificity of diagnoses," Kuchling told 

, noting that although the 2017 McDonald criteria were highly sensitive, they lacked specificity in real-world practice.

With the new criteria, there is hope for greater confidence in diagnosing MS and initiating treatment earlier in patients presenting with strong indicators such as CVS, without needing to consider other differential diagnoses like sarcoidosis or neuromyelitis optica spectrum disorder. However, Kuchling emphasized the importance of observing how the new criteria perform in clinical practice.

Marcello Moccia, MD, PhD, assistant professor at the University of Naples, explained to 

that a major advancement in the updated criteria is the transition from viewing MS as a purely clinical diagnosis to recognizing it as a biological disease. "This shift is evident in two key aspects of the criteria," he said. The first involves RIS, which was previously described as a set of MRI findings but can now be diagnosed as MS in specific cases where biological evidence of the disease is present. Additionally, the criteria for relapsing and progressive forms of MS have been unified.

"In the past, we used two separate criteria for different clinical presentations, but biologically, the disease is the same," Moccia explained. He added that although this change may have a minimal impact on clinical practice, it significantly advances the understanding and interpretation of MS.

As the revised MS diagnostic criteria continue to evolve, several open questions remain for clinicians to take into future consideration. According to Montalban’s presentation, one area that may require further investigation could be the demonstration of DIT using advanced techniques such as visual evoked potentials (VEP) and OCT, which could offer more precise diagnostic insights. Additionally, the refinement of using PRLs and CVS as diagnostic tools in specific contexts may need further exploration according to Montalban and colleagues.

The criteria’s application to cases of solitary sclerosis and other atypical MS presentations also could warrant further study to ensure broader applicability. Another key question presented at ECTRIMS 2024 on future revision is how the criteria perform across diverse populations, particularly in regions like Asia and Latin America, where MS presentations and risk factors may differ. Finally, Montalban highlighted the integration of other emerging biomarkers for MS diagnosis, beyond the currently accepted standards, that could be an essential consideration in the future revisions.

"A lot of the discussion hinged on what we should do for the next round of criteria. Another point is that we change the criteria every few years, right? That's the model we've been using. But is there a different model that might work better, where we adjust the criteria more frequently as data is produced? We heard some of that,” said 

, associate professor of neurology at the Cleveland Clinic Lerner College of Medicine, told 

. “So, definitely, I think just because we have a new set of diagnostic criteria doesn't mean we've solved all the problems. We need to continue working on things and evolving how we make a diagnosis of MS."

The development of the revised McDonald diagnostic criteria represents a significant milestone in the field of MS for both clinicians and patients receiving care, supported by a forthcoming publication of a paper and diagnostic algorithm. As highlighted in the ECTRIMS 2024 presentation by experts, these updates are the result of extensive consultation with the wider MS community and are designed to address both current challenges and emerging insights.

Based on Montalban’s presentation, clinicians can expect additional papers planned to expand on specific aspects such as imaging advancements, visual system assessments, and the role of biomarkers. Overall, experts recognize that the implementation of these changes globally will possibly require careful consideration of resources, education for providers, and patient accessibility. Thus, a global education campaign may be essential to ensure that MS clinicians worldwide can adopt these criteria effectively into their practice, improving diagnostic accuracy and patient outcomes as well as addressing the unique challenges and perspectives of patients living with MS.

“In essence, the disease hasn’t changed but every few years, new criteria are introduced. The question is, what are these criteria really for? I think they serve several purposes. One is for non-specialists who need help in defining what the disease might be. I believe some of the additions to the new criteria—partly based on new technologies—have genuinely improved the criteria,” said 

, the William S. and Lois Stiles Edgerly Professor of Neurology at Yale School of Medicine, 

. “But ultimately, I should point out that the diagnosis of MS is a pathological diagnosis, and what we do clinically is add various measurements that increase the probability of making an accurate diagnosis.”

McDonald WI, Compston A, Edan G, et al. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann Neurol. 2001;50(1):121-127. doi:10.1002/ana.1032

Thompson AJ, Banwell BL, Barkhof F, et al. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018;17(2):162-173. doi:10.1016/S1474-4422(17)30470-2

Montalban X. 2024 Revisions of the McDonald Criteria. Presented at ECTRIMS Congress; September 18-20, 2024; Copenhagen, Denmark. Scientific Session 1: New diagnostic criteria.

European Committee for Treatment and Research in MS. McDonald Diagnostic Criteria. Accessed November 12, 2024. https://ectrims.eu/mcdonald-diagnostic-criteria#

Articles

Recent updates to the McDonald diagnostic criteria for multiple sclerosis (MS) aim to enhance diagnostic accuracy and timeliness, incorporating advanced imaging and biomarkers. These revisions, presented at the 2024 ECTRIMS Congress, include recognizing radiologically isolated syndrome as MS in specific cases, adding the optic nerve as a diagnostic location, and removing the requirement for dissemination in time. The criteria now apply uniformly to both primary progressive and relapsing-remitting MS. Future revisions may explore further integration of emerging biomarkers and diagnostic tools.

With new revisions of the MS diagnostic criteria being made, clinicians highlighted key updates and the broader implications it has for diagnosis, treatment, and healthcare practices worldwide.

Advancing the Diagnostic Criteria for Multiple Sclerosis: A New Era of Early Detection and Precision 

Epilepsy, a condition characterized by a lasting predisposition to generate spontaneous epileptic seizures, has several neurobiological, cognitive, and psychosocial effects that impact patients.

 One of the psychosocial effects, stigmatization, is a major contributor to the burden associated with the condition and it can also affect the families of those with the seizure disorder.

 Although there have been advancements in therapies to improve patient outcomes to, in turn, help improve the quality of life of patients and reduce stigma, it is still prevalent in many parts of the world.

There seems to be a lack of awareness of the treatment options that are available for patients and also of knowledge of resources to help patients who feel stigmatized in living with the condition. Despite this, the field of epilepsy has expanded its research in hopes of enhancing the lives of patients and reducing stigma. In recent conversations with 

® over the course of the year, clinicians provided their insight on what stigma currently looks like, how it impacts the patients, and how to address it in the clinical setting.

There are 2 types of stigma that patients with epilepsy experience—“enacted stigma,” which refers to episodes of discrimination against patients with epilepsy; and “felt stigma,” which refers to the shame associated with being epileptic and the fear of enacted stigma.

 Thus, stigma does not only materialize in the form of other people’s feelings against a patient, but it also occurs in the feelings of the patients themselves. For the patient, the feeling of stigmatization may have manifold negative effects such as social isolation, low self-esteem, reduced quality of life, and worsening of seizures.

These feelings, like having a low self-esteem, may stem from losing independence with certain activities such as driving, which can be dangerous to some patients if they have a seizure behind the wheel. In a review published in 

lead author Allan Krumholz, MD, the director of the Epilepsy Center and professor of neurology at University of Maryland School of Medicine, observed that driving is an important concern for providers who care for patients with epilepsy, enacting a desire for them to be well informed about relevant issues to properly manage their patients and protect themselves against lawsuits.

 The ability to not be codependent on others is a large part of feeling a higher quality of life for some patients with epilepsy, which, in turn, can reduce their feelings of stigma. Although, one solution is the use of new and effective antiseizure treatment to reduce the occurrence of seizures, and thus increase a patient’s ability to feel more confident in their own activities, such as driving.

“Many patients find having seizures, particularly if they're uncontrolled, stigmatizes them because it limits their opportunities at work, sometimes socially, they're not able to drive off. There’s an adverse effect of having seizures of stigma because you're in some way not able to take opportunities to drive, to socialize in the same way. Sometimes patients with recurring seizures, lose confidence or have mood problems,” Gregory Krauss, MD, professor of neurology at Johns Hopkins University School of Medicine, told 

“All these things can set patients aside from what they potentially could do,” Krauss continued. “I think it’s very important for patients not to give up and realize there's new treatments, potentially curative surgery, potentially curative, or new therapies that can make them seizure free. All those things that can be used to minimize adverse effects, get rid of the seizure, stop them completely, that can remove stigma because the epilepsy is controlled. I think that should be the goal, no adverse effects, no seizures, that will reduce stigma.

Krauss described a patient who was experiencing several seizures every month that impacted not only his daily work on a farm, but his confidence in social circles; his wife would drive him to meet with friends for dinner, and they would switch seats once arriving at the restaurant so it would appear he had driven himself.

“He's now seizure free for about 6 years on a new treatment,” Krauss said. “He has confidence, he farms, and he drives. He's also teaching his kids to drive. These things really help in terms of minimizing stigma, which is to control seizures, and not to suffer adverse effects as you're doing it. But certainly, some people do not have controlled seizures, and it's just a medical condition. It doesn't constitute who the patients are. It's something to be dealt with and move on, try to be part of normal activities with some limitations such as driving.”

Nonpharmacologic Approaches to Stigma Reduction

Reducing stigma among patients with epilepsy does not have to always be done through effective pharmaceutical approaches, it can also be done through other ways such as behavioral and physiological interventions. In a systematized literature review published in 

 conducted by lead author Payal Chakraborty, PhD, postdoctoral research fellow in the department of population medicine at Harvard Medical School, and colleagues, 4 broad categories of stigma interventions were identified by the investigators. These categories included public awareness interventions, policy-based interventions, school-based interventions, and interventions that targeted the patients themselves, as well as their caregivers and their peers.

 These interventions help to empower the patients and bring a sense of positivity in the patient community. Interventions that involve policy, awareness, and academics all contribute to creating a safe space for patients with epilepsy so they can avoid not feeling judged or isolated.

Interventions that target the patients themselves are another type of method to reduce stigma, such as physical approaches like exercise regimens. One exercise approach used among these patients is yoga, which requires mindfulness of the body and brain while doing stretching positions. Recent research shows that this type of exercise can alleviate the burden of epilepsy and improve the overall quality of life in patients by reducing perceived stigma.

 The exercise can be done anywhere, as well, whether it is performed remotely from watching a stream of a yoga class or going to one in person. There are also benefits to doing these types of exercises in a community setting to feel not only more connected to oneself but also to the other people.

 Although there are different types of interventions to address stigma in epilepsy, the effectiveness for reducing it depends on the individual person and thus should be a targeted, personalized intervention.

“Stigma must be specifically addressed with each person.It can be a true barrier to appropriate care. Our support groups really help with stigma as the peer-to-peer connection can make people feel less alone. Epilepsy is particularly susceptible to stigma as a seizure is a profound loss of control and a big seizure can look terrifying, which historically has been thought of as a spiritual illness (possession by the devil). Constant raising of awareness of epilepsy as a medical condition, education of the patient and their families and willingness to talk to other people that are important to the patient helps with stigma. Facing the truth, naming it, and helping with fear improves care because it allows patients to really discuss their concerns and dig into treatment, “ Lara V. Marcuse, MD, and Madeline Fields, MD, both codirectors of the Mount Sinai Epilepsy Program, The Icahn School of Medicine at Mount Sinai, told 

Community holds an important role for patients who are living with a difficult neurological condition such as epilepsy because of the socialization and understanding that can be built in those settings. There are several patient advocacy organizations that share resources for those looking to relate to other people and learn more on how they can personally manage their condition, besides simply having a conversation about it with their provider. Many of these patient foundations have conducted research, awarded grants, and have supplied patients with the information they may need to seek better care for themselves.

These organizations also promote awareness for the condition, especially by holding awareness events during the year or at medical conferences by helping to share new updates on potential therapies. They also help patients to get connected to support group programs which can be successfully implemented in the community and are associated with improved outcomes in adults with epilepsy—particularly those with mental health conditions.

 In other research, findings showed that group participation in general demonstrated significant benefit among adults with long-term disease in aspects of pain, psychological outcomes, self-efficacy, self-care, and quality of life.

 The epilepsy community that is put together by not only the organizers but other stakeholders has helped patients in being more empowered to manage their condition through awareness brought by education to reduce stigma.

“I think a lot of it is education. It's education for providers to talk about these new opportunities and it's also education for patients and caregivers to learn about these new opportunities to not give up and strive for better seizure control,” Danielle Becker, MD, MS, FAES, division director of epilepsy and associate professor of neurology at The Ohio State University Wexner Medical Center, told 

. “The goal would be to strive for zero seizures, if possible, and for providers and patients as well as caregivers to learn that there are new opportunities coming out there. Even if opportunities may not have worked in the past, newer developments may work. As far as stigma, I really think it's about education, about how to improve quality of life, reduce drug load, and reduce cognition. How to normalize the lives of patients potentially with epilepsy, but also try to give back some of that independence that's been taken away.”

Addressing Stigma With In-Clinic Communication

In the clinical setting, clinicians can help by emphasizing the importance of the preferred style of communication with patients, making sure that they feel more in control of the decisions that they want to make moving forward with their treatment. In addition, having effective communication between both the provider and patient is recognized as of the utmost importance to improve the quality of care for the patients with epilepsy.

 In performing this communication, physicians can increase their patients’ knowledge and perceptions about epilepsy—but it will require a significant increase in ongoing efforts for educational programs to eliminate stigma and improve access to care.

, lead author Jerry Paul K. Ninnoni , PhD, the head of department of mental health at the University of Cape Coast School of Nursing and Midwifery in Cape Coast, Ghana, observed that patients who have learning disabilities and live with epilepsy (as well as their caregivers) would like to be more informed about their disease to be more involved in decision making and management of the condition.

 Another form of effective communication is motivational interviewing, which is a method of motivating patients to engage in a behavior modification process to have an empowering conversations with patients.

 Experts in epilepsy have highlighted that patients still face a lot of unmet needs in terms of treatment and diagnosis, but there is also the unmet need of reducing self-felt stigma. Therefore, a shift in communication methods in the clinic could help these patients feel more empowered to not only control their seizures, but also live their lives with confidence.

“Epilepsy still does carry stigma with it, [but] maybe less so in the US and Europe than in other parts of the world. In India, it's still a reason to abandon marriage—if either party has epilepsy—and so it is in many parts of the world. So being aware of it as a disease; that is, a disease in the same way as diabetes [is], but in a way with a greater emotional impact because of the tremendous insecurity that you have as a patient,” Pavel Klein, MD, director of the Mid-Atlantic Epilepsy & Sleep Center and adjunct associate professor of neurology at George Washington University, told 

“For instance,” Klein said, “knowing that at any point you could lose consciousness, fall to the ground, look unpleasant with writhing and foaming at the mouth, or even urinating on yourself in a store while shopping. All these things that can happen, and you don't know when they could happen. We can live in fear of it all the time. Having other people, family, friends, schools, employment, being aware of that and being supportive is very important.”

Looking to the future, these aforementioned strategies are effective ways to reduce stigma among patients with epilepsy. This includes the administration of effective therapies or nonpharmalogical treatments to help improve mood. There is also the involvement of patient advocacy organizations that help to connect patients with others who may be experiencing similar medical issues with their condition and offer them resources for their care journey. In addition to patients speaking with others with epilepsy, there is also a need for effective communication between the clinicians. Having a clear line of communication, and using tactics like motivational interviewing, can help the patient recognize that they have the power to manage their seizures and live a higher quality of life. All of these aspects for reducing stigma are underscored by clinicians in the field of epilepsy and are strongly recommended for new year and beyond—particularly in a world where treatments can dramatically alter the lives of patients, even those with refractory epilepsy.

“It's remarkable how in this day of instant communication across the globe, there is still a lack of awareness of new treatments both among healthcare professionals and patients. It is relevant for general practitioners to be aware of these new treatment options that really can put stay to the disease. Many physicians think that if you have 1 seizure a month, it's not a big deal. They may consider that the patient is controlled enough, but it is a big deal,” Klein said.

Klein advocated for his peers to pursue seizure-free treatment outcomes for any eligible patients—a realistic and life-changing opportunity in 2023 and beyond.

“I also think it is a very important goal to strive for in terms of educating society, and then the same goes at the other end of the spectrum,” he added. “I think patients should be aware that there are options—and if they're not being treated with those, with all the options that are out there, it's not right. General awareness of both epilepsy to reduce the stigma, but also of change in the treatment options, such that previously resistant refractory epilepsy that could now potentially be successfully treated, is important.”

Fisher RS, Acevedo C, Arzimanoglou A, et al. ILAE official report: a practical clinical definition of epilepsy. 

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Henning O, Buer C, Nakken KO, Lossius MI. People with epilepsy still feel stigmatized. 

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Krumholz A. Driving issues in epilepsy: past, present, and future. Epilepsy Curr. 2009 Mar-Apr;9(2):31-5. doi: 10.1111/j.1535-7511.2008.01283.x. PMID: 19421374; PMCID: PMC2673400.

Chakraborty P, Sanchez NA, Kaddumukasa M, et al. Stigma reduction interventions for epilepsy: A systematized literature review. 

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Kaur K, Sharma G, Dwivedi R, et al. Effectiveness of Yoga Intervention in Reducing Felt Stigma in Adults With Epilepsy: A Randomized Controlled Trial. 

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Sajatovic M, Needham K, Colón-Zimmermann K, Richter N, Liu H, Garrity J, Ryan ER, Storer N, Harper V. The Community-targeted Self-management of Epilepsy and Mental Illness (C-TIME) initiative: A research, community, and healthcare administration partnership to reduce epilepsy burden. Epilepsy Behav. 2018 Dec;89:175-180. doi: 10.1016/j.yebeh.2018.10.004. Epub 2018 Oct 29. PMID: 30385215; PMCID: PMC7484726.

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In recent conversations with experts in epilepsy, the impact of stigmatization remains high for patients and ongoing efforts by clinicians to address this issue in the clinical setting has been underscored, despite the global lack of awareness about new treatments and other resources.

Stigma in Epilepsy in 2023: How Far Have We Come?

 field have experienced both progress and challenges. The insomnia care paradigm in particular saw treatment advances such aspharmacological therapy with the FDA approval of daridorexant (Quviviq; Idorisa), following the 2019 greenlight of lemborexant (Dayvigo; Eisai), as well as more data on cognitive behavioral therapy (CBT), which has become a recommended treatment for patients.

Challenges, though, persisted. Conversations about the impact of daylight saving time and its effect on patients’ sleep health were ongoing, as were those focused on school start times and pediatric sleep. Another major challenge that has been reported in the literature that needs more research is substance use, which has been shown to have significant effects on sleep. 

Overall, in conversations with NeurologyLive® over the course of this year, sleep medicine physicians indicated that the future of sleep care for conditions like insomnia appears to be moving toward a digital approach with artificial intelligence (AI), digital CBT, and wearable devices. This future holds much hope for those caring for patients, even with the various challenges that lie ahead. Ultimately, a better scientific understanding of sleep’s overall effects on health and an exacerbation of sleep conditions by societal issues has brought sleep health to the forefront of population health conversations.

One of the most recently approved therapies for insomnia is daridorexant, which got the FDA go-ahead on January 7, 2022. Shortly after the approval, Thomas Roth, PhD, the director of the Sleep Disorders and Research Center at Henry Ford Hospital, and an investigator in the clinical development studies of the newly approved Idorsia therapy, offered theclinician perspective on the efficacy and safety profiles from the study as well ashis other takeaways.

On the day of the decision, he noted in a statement that contextually it is important to remember that insomnia “is not only a problem of the night, but affects a patient’s ability to function during the day,” adding that, “elevating the [awareness about the] impact insomnia has on both the night and day remains critical in addressing patients’ needs.”

Martine Clozel, MD, the chief scientific officer at Idorsia, also said in a statement,

 that the companydesigned daridorexantwith the goal of “help[ing] address several issues people with insomnia face. Daridorexant properties include a potent inhibition of both orexin receptors, a rapid absorption for sleep onset, and a pharmacokinetic profile such that around 80% of daridorexant has been eliminated after a night of sleep to help minimize residual effects."

Another therapy that was approved and continues to be beneficial for individuals with insomnia is lembroexant. A recent study from the post-hoc analysis of Study 303 (NCT02952820) demonstrated that those who had clinically meaningful reductions on Insomnia Severity Index (ISI) scores reported greater changes from baseline in several outcome measures. The treatment was approved in 2019 for insomnia and has been used in different analyses studies since then. The Study 303 analysis suggested that most patients on lembroexant experience a positive medication effect.

In recent years, treating sleep disorders including insomnia with CBThas become a recommended approach, but there have been challenges in increasing its use. Yuri Maricich, MD, MBA, an internal medicine physician, and chief medical officer and head of development at Pear Therapeutics, recently published data along with a group of investigators froma real-world cohort of individuals that utilized a digital therapeutic called Somryst (previously known as SHUTi) which evaluates healthcare resource utilization, associated costs, and insomnia severity effects of the therapy.

“There’s been a lot of work looking at the importance of—and what is addressed in the clinical guidelines—cognitive behavioral therapy for insomnia, but unfortunately, the vast majority of patients can’t get access [to it] because there are only 600 clinicians who are trained, and less than 400 who are even certified,” Maricich told NeurologyLive® in an interview where he shared his perspectives on the motivations for the real-world use of CBT interventions. 

Similarly, Michelle Chen, PhD, a neuropsychologist at Rutgers University and core member at the Institute for Health at Rutgers, told NeurologyLive® that CBT is the gold standard for treating insomnia. She noted that its effectiveness lies in part because it teaches patients what the best habits are to promote good sleep—not necessarily changing the brain chemistry of the patient. Additionally, it lacks as many adverse effects as pharmacologic medications.

Additionally, another nonpharmacological approach that has become more widespread recently in clinical care is the incorporation of AI. The use of AI technology in sleep medicine has assisted with improving the labor-intensive acts of monitoring and scoring sleep stages. One such AI effort is being spearheaded by the American Academy of Sleep Medicine (AASM), which has established a 2-year pilot program called the AI/Autoscoring Certification Program that will focus on polysomnograms for sleep stage scoring and whether the software demonstrates equivalent or better accuracy than manual scoring.

Anuja Bandyopadhyay, MD, an assistant professor of clinical pediatrics at Indiana University School of Medicine, and the chair of the AASM’s Artificial Intelligence in Sleep Medicine Committee, spoke with NeurologyLive® about her perspective on the state of understanding insomnia, and how better phenotype-specific treatment can improve care. “We didn’t really realize that there could be different phenotypes, different clinical expressions of the same disease. So, a person with sleep apnea and insomnia is very different from a person with depression and insomnia, not just in the clinical expression, but in how they respond to different medications,” Bandyopadhyay said.

Other types of nonpharmacological interventions for insomnia include listening to music. One example from research this year comes from a review of randomized controlled trials. The updated review showed thatmusic potentially can be an effective approach for the improvement of subjective sleep quality for adults that experience insomnia symptoms.

Listening to music has been known to be used as a sleeping aid and can be an effective nonpharmacological intervention for improving insomnia symptoms in adults, according to the review.

Lead investigator Kira Jespersen, PhD, MSc, an assistant professor in the Center for Music in the Brain and the Department of Clinical Medicine at Aarhus University & The Royal Academy of Music Aarhus/Aalborg, in Aarhus, Denmark, and colleagues wrote, “Listening to music may improve slightly sleep‐onset latency (how quickly a person falls asleep), sleep duration (length of time a person is asleep) and sleep efficiency (amount of a time a person is asleep compared to the total time spent in bed), compared to no treatment or treatment as usual. None of the studies reported any negative effects caused by listening to music.”

School start times have been another hot topic in sleep and have been shown to have an impact on pediatric circadian rhythms. These unhealthy sleep patterns can carry on from childhood into adulthood. And although sleep disorders may be common in some children and adolescents influenced by lifestyle behaviors, others could be from the cause of a neurological condition, making their recognition imperative. Carol Rosen, MD, a professor of pediatrics at Case Western University, has concerns about the transition period before school begins, when children start going to bed earlier and adjusting their internal clock.

"Figure out what the schedule is, how much sleep your child needs, and kind of work backwards. Maybe go back in 15- or 30-minute increments, starting with your wakeup time. Move that back," Rosensaid in an interview with NeurologyLive® where she shared the advice she’s given to parents.

Chris Winter, MD, owner of Charlottesville Neurology and Sleep Medicine clinic and CNSM Consulting, and an author of several books on sleep, also shared his perspective on pediatric sleep on the Mindful Moments® podcast. He summarized the state of pediatric sleep disorders and provided some thoughts on the current system of schooling and how it impacts the sleep health of children along. He also expanded on the current trends in sleep medicine research, and what issues—such as recognition of sleep disorders—need to be addressed.

Children that experience poor sleep may also have their moods impacted as well. "When you’re cranky, it affects emotional regulation," Jodi Mindell, PhD, told NeurologyLive®. “How can you keep it together? Do you get angry much more easily? Do you burst out into tears? Do you start laughing and can’t control it? The kid whose super silly in school may be because they can’t regulate their emotions because they’re not getting enough sleep."Mindell, a psychologist in the Department of Child Adolescent Psychiatry and Behavioral Sciences, and the associate director of the Sleep Center at the Children’s Hospital of Philadelphia (CHOP), explained that there are 5 main domains of sleep-related issues in children and adolescents: mood, cognition, behavior, health, and families.

Seema Khosla, MD, FCCP, FAASM, the medical director of the North Dakota Center for Sleep, was also interviewed by NeurologyLive®, for the Mindful Moments® podcast, about the AASM’s current stance on another societal effect on sleep health—and not just on children, but adults as well—daylight saving time. Kholsa offered insight into the academy’s ongoing initiative to switch to a fixed standard time year-round and provided an expert opinion on how it might help address the impact on circadian rhythm.

Earlier in the year, the Sunshine Protection Act was passed by the US Senate, legislation that would make daylight saving time permanent starting in 2023. In response to the bill, the AASM released a statement further expressing its gratitude to the Senate. Although, the AASM also advised the House of Representatives to take more time in assessing the potential ramifications of establishing this permanent daylight savings time, and plan for the future with health in mind.

Another ongoing point of discussion was the effects of various substances on sleep health, including alcohol and cannabis, among others. Based on recent research this year, the frequency of alcohol and cannabis use may be strongly associated with insomnia-related symptoms from poor sleep quality. Investigator Wendy Troxel, PhD, a senior behavioral scientist at the RAND Corporation,told NeurologyLive®that, according to her observed research, “We found in looking at longitudinal profiles of sleep that having poor sleep quality alone or in combination with other dimensions of disrupted sleep was associated with higher frequency of alcohol use at baseline and greater increases in alcohol use over time, as compared to other sleep profiles with good sleep quality.”

Among these concerns are still some lingering challenges when it comes to the treatment of insomnia. Despite progress, there are a few nonpharmacological interventions available. Other recommendations for patients to improve their sleep health include incorporating positive lifestyle changes that may alleviate symptoms suchas changingthe sleep area or schedule, avoiding big meals and alcohol before bed, and staying active—but implementing behavioral changes often prove difficult in practice. However, if behavioral interventionsare ineffective method for the patient experiencing insomnia, then the pharmacological treatments may provide a better route for patients to take.

Ashgan A. Elshinawy, DO, a pulmonologist at Penn Medicine, believes that from both the clinician and patient perspectives, patience is the most important aspect of care. Elshinawy discussed some of the present challengesin caring for patients with insomniaduring an interview with NeurologyLive®,and mentioned some of the biggest priorities for the future with improving the paradigm.

COVID-19 has been anotherfactor impacting individuals with insomnia as the pandemic has been associated with an increase in symptoms of insomnia based on prior research from this year. Lead author of an investigational analysis on the topic, Maha Meshal Alrasheed, PhD, MSc, an associate professor in the Clinical Pharmacy Department at the College of Pharmacy of King Saud University, wrote that their data, “suggests that the COVID-19 pandemic is associated specifically with a marked increase in the rates of subthreshold insomnia symptoms but not moderate or severe insomnia.”

Alrasheed and colleagues found statistically significant differences between countries for all severities of insomnia symptoms in their assessment. Notably, neither age nor sex appeared to be moderators of the cumulative prevalence of subthreshold insomnia symptoms or of clinically significant insomnia.

“Over the past couple years, in the wake of the COVID-19 pandemic, sleep in general is having a moment.Insomnia specificallydefinitely has grown in the public awareness of what a problem it is. Insomnia rates were rising considerably during the pandemic, particularly during the stay-at home orders, really raising the salience of sleep problems, across the population. From young people to old people, many people, even more so than before, are aware of it,” Troxel told NeurologyLive®. She added that insomnia has been the most common sleep disorder for quite some time, affecting more than 50 million adults in the United States alone.

Troxel noted that the future is bright, though. Growth in awareness often lends itself to progress in research, and Troxel explained that progress has been made in the development of interventions not only at the individual level but the community level. The work of the AASM and other organizations has begun to lead to policy decisions and changes, making sleep health a priority at a population health level. All in all, it points to a growth in understanding about sleep’s impact on general health and comorbidity—and as one improves, so does the other. “I think, resolving any sleep issues or trying to help patients sleep better, for most conditions, usually would lead to better functioning because sleep is so important. If you have poor sleep, it's hard for people to be productive. It can often exacerbate a lot of other conditions and other symptoms such as fatigue, cognition, mood, and so on,” Chen said.

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3. Pear Therapeutics Announces Publication of New Analysis of Real-World Data Showing Reduction in Insomnia Severity, Healthcare Resource Utilization and Associated Costs in Adults Using Somryst®. News release. Pear Therapeutics. August 10, 2022. Accessed August 25, 2022. https://peartherapeutics.com/pear-therapeutics-announces-publication-of-new-analysis-of-real-world-data-showing-reduction-in-insomnia-severity-healthcare-resource-utilization-and-associated-costs-in-adults-using-somryst/
4. Jespersen KV, Pando-Naude V, Koenig J, Jennum P, Vuust P. Listening to music for insomnia in adults. Cochrane Database Syst Rev. 2022;8(8):CD010459. Published 2022 Aug 24. doi:10.1002/14651858.CD010459.pub3

The past year has provided great steps forward in sleep science, and coupled with the lingering difficulties in care and the COVID-19 pandemic’s effects, the field is coming to a head to make sleep health a public health priority.