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Sleep Disorders and Social Security– What You Need to Know

Social Security Disability Series: Part 2

Sleep Disorders and Social Security Disability – What You Need to Know

By Anjel Burgess, JD

Jennie has been fortunate enough to secure her short-term disability benefits. She has also hired an Attorney to assist her with the Social Security Disability application process. Although her family encouraged her to “file on her own instead of paying out of pocket to hire an attorney,” Jennie has learned throughSomnusNooze that Social Security Disability attorneys are not paid by a retainer, as many attorneys are. Rather, they work on a contingency basis, which means that Jennie does not have to pay out of pocket to get representation. For the attorney to get paid, two conditions must be met:

  1. The attorney must win Jennie’s case.
  2. Jennie must be entitled to past-due benefits (also known as back pay).

If both conditions are met, the Social Security Administration (SSA) will pay Jennie’s attorney 25% of Jennie’s back pay, up to a maximum of $6,000. Since obtaining the benefits is of the utmost importance to Jennie, she has decided that she can’t afford NOT to have an attorney. She has hired an attorney who will file an initial application for her and represent her through each step of the process.

Jennie’s attorney has explained to her that most people who receive Social Security Disability benefits have been through a three-step process and that it may take two years or more before she is approved (note that in some states, it is a 2-step process, as the Reconsideration step is eliminated). These steps include the following.

  1. Initial – Roughly 30% to 35% of applicants are approved at this level. Once SSA receives the initial application, they request medical records from Jennie’s providers. Once the SSA receives Jennie’s medical records, SSA will have its own physician or psychologist (or both a physician and psychologist) review the medical records to give their opinion as to what limitations they believe that Jennie has, as well as the impact of those limitations on her ability to work. This would also include a review of the opinion of Dr. Wonderful and any other of Jennie’s treating physicians. Oftentimes, SSA will decide that they need an outside opinion in making their decision. If this occurs, the SSA may require that Jennie be examined by an independent physician or psychologist (at SSA’s expense) who may not have an expertise in idiopathic hypersomnia. This independent professional then prepares a report that summarizes her or his observations and professional opinion. If the case is denied initially, Jennie can appeal.
  2.  Reconsideration – Roughly 7% to 10% of applicants are approved at this level. At the Reconsideration step, SSA obtains updated medical records and completes another internal review of Jennie’s file to see if any new evidence would result in a favorable outcome. It is possible that the SSA may send Jennie out for an independent examination at this stage as well. Again, if Jennie is denied, she can appeal.
  3. Hearing – Roughly 50% to 55% of the remaining applicants are approved at this level. This is the stage at which most people are awarded benefits, particularly after attending a hearing in front of an administrative law judge. The hearing is the opportunity for Jennie and her attorney to present the big picture to a judge. The big picture includes all medical records and testimony from Jennie herself. Jennie’s attorney will also have the opportunity to make oral and written arguments on Jennie’s behalf.

The common theme in each step of the process is medical records. Medical records are vital in a disability case because they can provide objective support for an individual’s complaints. For Jennie, her medical records tell the story of a very symptomatic individual who tried multiple medications but could only be productive for about 3 hours throughout the day. Her doctor ruled out many other conditions, and was able to confirm the diagnosis of idiopathic hypersomnia via a polysomnogram and Multiple Sleep Latency Test. Jennie’s medical records provide proof that she has idiopathic hypersomnia and authenticate her symptoms, which are reasonably due to idiopathic hypersomnia.

If you, too, are ready to file for Social Security Disability or have been denied at any step in the process, contact a qualified Social Security Disability Attorney to assist you with the process.

Anjel Burgess is a partner/attorney at the Law Firm of Burgess and Christensen located in Marietta, GA. She exclusively practices Social Security Disability Law for adults and children, as well as the ancillary areas of Guardianships and Special Needs Trusts. By doing so, she has been able to make a positive difference in the daily lives of people who need help the most. You may reach her at Anjel@DisabilityHelpLine.com or 770-422-8111. You can learn more about her services at www.DisabilityHelpLine.com

Have you joined the registry yet?
A patient registry is a collection that is established to collect standardized information about a group of patients who share a common condition or experience. In the case of the Hypersomnia Foundation Registry at CoRDS  (Coordination of Rare Diseases at Sanford), the people who participate have one of the central disorders of hypersomnolence: idiopathic hypersomnia, Kleine-Levin syndrome, or narcolepsy (type 1 or 2). Becoming part of the registry is easy and it could help solve the puzzle of hypersomnia! Simply go to http://www.sanfordresearch.org/cords/ and click on the ENROLL NOW button.

A patient registry is a collection that is established to collect standardized information about a group of patients who share a common condition or experience. In the case of the Hypersomnia Foundation Registry at CoRDS (Coordination of Rare Diseases at Sanford), the people who participate have one of the central disorders of hypersomnolence: idiopathic hypersomnia, Kleine-Levin syndrome, or narcolepsy (type 1 or 2). Becoming part of the registry is easy and it could help solve the puzzle of hypersomnia! Simply go to http://www.sanfordresearch.org/cords/ and click on the ENROLL NOW button.

 

Watch Beyond Sleepy in the Mile-High City

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Were you one of the more than 1250 people who joined us at Beyond Sleepy in the Mile-High City, the Hypersomnia Foundation’s Regional Conference, in person and online on June 12, 2016? If not, you can still watch the conference in its entirety by registering at http://www.hypersomniafoundation.org/2016-hypersomnia-regional-conference-register/. If you previously registered and missed any part of the program–or simply want to watch it again–please go to http://www.hypersomniafoundation.org/2016-hypersomnia-regional-conference-live/. The video will only be up for two more weeks!

 

Posted in: Action, Awareness, BeyondSleepy, Conference, CoRDS Registry, Education, Hypersomnia, idiopathic hypersomna, Kleine-Levin syndrome, narcolepsy, News, SomnusNooze, SSDI

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Act Today and Let Your Voice Be Heard

Very recently, the Hypersomnia Foundation became aware of an opportunity to help shape the future of sleep research. The National Institutes of Health, the primary source of funding for medical research in the United States, has issued a Request for Information, which you can view at: https://grants.nih.gov/grants/guide/notice-files/NOT-HL-16-312.html.

The final date to submit your comments has been extended to today, May 16, 2016.Screen Shot 2016-05-16 at 12.41.44 PM

Last week, we sent an email to everyone in our database to encourage you to make your voices heard. We are urging you again to act today. Please share your hypersomnia story with the people who determine medical research priorities and allocate funds.

  • Tell them why the currently available diagnostic tools and lack of awareness about hypersomnia led to a lengthy delay in your diagnosis.
  • Tell them why research into the cause of and effective treatments for hypersomnia are so desperately needed.
  • Tell them why we need a cure as soon as possible because hypersomnia is limiting your ability to achieve your dreams, complete your education, or even provide financially for your family.

Please join your voice with ours as we fight to secure the place of hypersomnia at the top of the nation’s sleep research agenda. The Hypersomnia Foundation Board of Directors has submitted the following response, and we encourage you to send your comments and suggestions to the NIH, as you deem appropriate, at rfi-sleepplan2016@collaboration.nhlbi.nih.gov.


 

Hypersomnia Foundation Response
to the National Institutes of Health’s Request for Information:

For nearly a century, the study of sleep and its function(s) in health and disease has been principally focused within approaches that center on not enough sleep. Although excessive daytime sleepiness (EDS), cognitive dissonance, and other symptoms not surprisingly result from sleep deprivation, central disorders of hypersomnolence (CDH; e.g., idiopathic hypersomnia, Kleine-Levin syndrome,
narcolepsy type 1 [NT1], and narcolepsy type 2 [NT2]) in humans (in which EDS is often accompanied by extremes of sleep length) emerge spontaneously. Studying patients with CDH has already proven to be fertile ground for investigation, as evidenced by the discovery that loss of brain hypocretin causes narcolepsy with
cataplexy (i.e., NT1). Yet, for the other CDH, there remains a large unmet clinical need, with further research and development prime for discovery and the potential for extraordinary translational opportunities.

Symptoms of CDH can be disabling, and because, for example in NT1, they also begin in adolescence or young adulthood, are chronic, sometimes progressive, go undiagnosed or misdiagnosed for decades, and respond variably to medications.
Despite advances around NT1, the knowledge gained has not translated smoothly to
the clinical realm. Diagnoses of CDH inclusive of NT1 since 1975 have relied upon a
forty-year-old test (viz., the Multiple Sleep Latency Test [MSLT]) that is cost, time,
and labor intensive and that was born of practical necessity and subsequently
tweaked to specifically identify NT1. In 2006, two preeminent sleep researchers concluded that the MSLT yields “a large number of false-positives” and that an increased daytime propensity to REM-sleep—traditionally accepted to be the sole domain of NT1—does “not appear to have any specific pathognomonic significance.” Yet, in 2016, the MSLT remains the gold standard that drives diagnoses and all that it implies. For clinician scientists, this means, for example, how clinical trials are designed and studies of heritability are conducted. Even more so, for patients, this has enormous implications for prognosis, treatment choice, access to medication(s), and accommodations/disability status.

There are currently no FDA-approved treatments for the CDH—medication choice being limited to those for narcolepsy. Since the 1930s, conventional
psychostimulants such as ephedrine have been used to treat NT1. The majority of the current pharmacological armamentarium and drug development are similarly designed and focused upon promoting wakefulness by enhancing brain monoamines. Drugs more directly designed to replace hypocretin continue in development 16 years after the discovery of hypocretin. An alternative construct in approaching the biology and treatment of CDH has recently been proposed that appears to hold great promise for many patients. People with CDH without NT1 (i.e., hypocretin being intact) do not appear to suffer from any “loss of function” per se but, rather, a gain of function in sleep-promoting brain circuits. Thus, pharmacologic agents that antagonize the sleep-promoting and consciousness-dampening neurotransmitter gammaaminobutyric acid (GABA), such as flumazenil, clarithromycin, and pentylenetetrazol, have either been demonstrated to be effective or are in clinical trials for CDH patients in whom traditional wake-promoting agents have not been helpful.

We advocate for initiatives to fund discovery research that translates to improve the human condition of people with CDH in whom sleep is prolonged and ostensibly persists into “wake.” Enhanced recognition and improved treatments call for greater understanding of not only the clinical spectrum of CDH and the natural history of these disorders, but also mechanistic understanding of their biological underpinnings. Diagnostic tools that are highly discriminative and designed to capture more than just EDS and an increased daytime propensity to REM sleep are an absolute necessity. CDH remain diagnoses of exclusion such that greater understanding of potential mimics—which themselves would enhance mechanistic understanding of sleep—and biomarker discovery are also high priorities. As there are numerous stakeholders in such endeavors, as evidenced in the summary provided above, the absolute need to encourage greater dialogue and collaboration among patients, patient advocacy groups, professional organizations representing sleep physicians, funding agencies, and industry cannot be understated. With increasing dissemination of knowledge through many means, not the least of which includes social media, patient consumers with CDH-like symptoms have become increasingly knowledgeable. They are acutely aware that CDH outside the realm of NT1 is not well served by current medical knowledge or practice in this realm. Accepting the status quo risks alienating the public and medical consumer.

We would, therefore, propose including a sleep neurobiologist on the NHLBI Sleep
Disorders Research Advisory Board and developing mechanisms for solicitation of
program projects and set-aside funds specifically to research hypersomnia, with requests for proposals to prioritize filling unmet clinical needs in the following areas:

R37 Javits Neuroscience Investigator Award
NIH EUREKA grants
R13 funding to support conferences
T32 grants for postdoctoral study
RFAs and more specifically RFPs
SBRI funding for better diagnostic tools

Because the breadth of scientific inquiry or line of investigation needs incredible resources and sustainability, we would advocate for funding initiatives with set-aside monies at all levels of training, including predoctoral, doctoral, postdoctoral, junior investigator, and senior investigators, and we envision promoting set-aside monies for all the Career Development K Awards for investigators with projects relevant to CDH.


 

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Learn about the latest hypersomnia research on June 12th at the Hypersomnia Foundation’s regional conference, Beyond Sleepy in the Mile High City. Scientists will share findings from their recently completed clinical trials and other ongoing studies, lead us on a journey through the drug discovery and approval process, and help us to cope with the daily struggles of hypersomnia. You will also learn how your future participation in the registry can help to solve the puzzle of hypersomnia.

Tickets are running out so order your $25 ticket online to join us in person in Denver or wait until June 1 to sign up for a live Internet stream of the conference, brought to you free of charge through the generous support of Balance Therapeutics, Inc., and Flamel Technologies, SA.

 

 

 

Posted in: Action, Awareness, Education, Hypersomnia, idiopathic hypersomna, Kleine-Levin syndrome, narcolepsy, News, Research, SomnusNooze

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Calcium-dependent Pathway Helps to Regulate Sleep Duration

Background

How do our brains control when we go to sleep and when we wake up? Previous studies have tried to answer this question, but, despite years of research, our understanding of this process is incomplete. Therefore, the goal of this study was to identify the elusive mechanisms underlying the control of sleep.

Who were the researchers and what did they do?

Dr. Ueda and colleagues at the University of Tokyo constructed a computer model (called computational modeling) of a neuron (a type of cell in the brain) during sleep to predict what pathway(s) might be responsible for sleep regulation. They then manipulated the proposed pathway in mice to test if the computer model was correct. Dr. Ueda and colleagues employed cutting-edge techniques to either remove the proposed pathway gene products from mice using genetic engineering (called knockout mice), or block the proposed pathway gene products using drugs (called pharmacologic inhibition). The authors then measured how these experimental manipulations of the proposed pathway in mice impacted sleep.

What were the results of the study?

This study revealed that the proposed pathway from the computational model does indeed control sleep duration in mice. Seven genes involved in the pathway emerged as having effects on sleep duration, out of a total 21 examined. The identified genes are involved in the regulation of a calcium-dependent pathway in neurons. Interestingly, changes in this calcium-dependent pathway can increase or decrease sleep duration.

What are the authors’ conclusions?

The authors conclude that this calcium-dependent pathway helps to regulate sleep duration. Future research in this pathway may help uncover the “missing switch between sleep/wake cycles.” This crucial research will lead to a better understanding of normal sleep function, in addition to associated sleep and psychiatric disorders. 

 

Tatsuki F, Sunagawa GA, Shi S, et al. Involvement of Ca(2+)-dependent hyperpolarization in sleep duration in mammals. Neuron. 2016;90(1):70-85.

A video overview of this research is available from the authors at https://www.youtube.com/watch?v=W4NrSa1R4mU

 

 

Conference rectangle Image
Learn about the latest hypersomnia research on June 12th at the Hypersomnia Foundation’s regional conference, Beyond Sleepy in the Mile High City. Scientists will share findings from their recently completed clinical trials and other ongoing studies, lead us on a journey through the drug discovery and approval process, and help us to cope with the daily struggles of hypersomnia. You will also learn how your future participation in the registry can help to solve the puzzle of hypersomnia.

Order your $25 ticket on line to join us in person in Denver or wait until June 1 to sign up for a live Internet stream of the conference, brought to you free of charge through the generous support of Balance Therapeutics, Inc., and Flamel Technologies, SA.

Posted in: Conference, News, Research, SomnusNooze

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2015 HF Year in Review

“Overwhelmed!” “Excited!” “Incredibly grateful!”at the Hypersomnia Foundation, we are thrilled beyond belief  following our “Giving Tuesday” campaign that expanded beyond a single day and actually ran through the end of 2015. Your incredible generosity not only met, but far exceeded, the Board members’ challenge to match their pledges.

Inspired by your support and encouragement, we will make 2016, our third year, the Hypersomnia Foundation’s most effective and successful year. But, before we look forward, let’s take a moment to reflect on what you—the Hypersomnia Foundation’s donors, volunteers and supporters—made possible in 2015.

  • The National Institute of Neurological Disorders and Stroke at the National Institutes of Health includes the Hypersomnia Foundation as a source of information on hypersomnia; http://www.ninds.nih.gov/disorders/hypersomnia/hypersomnia.htm.
  • The Board of Directors has expanded to seven members, who bring diverse knowledge and perspectives toward achieving the Foundation’s mission.
  • The Medical Advisory Board, now comprising six world-renowned clinicians, reviews and approves all medical information that the Hypersomnia Foundation publishes.
  • Awareness is growing: more than 1000 people now receive the SomnusNooze newsletter at least once a week, and physicians’ offices have distributed more than 2,000 brochures.
  • The web-based Physician Directory launched in July and now provides contact information for more than 40 physicians.
  • The successful 2015 Hypersomnia Conference provided education and support for the 240 attendees, including people with hypersomnia, healthcare professionals, researchers, and supporters from 28 states and 5 countries. Dr. Isabelle Arnulf’s keynote presentation led the way to break-out sessions, physician roundtable discussions, and research updates.
  • SnoozeTV – created in 2015, and presented as a live-interactive broadcast through Google Hangout, will be undergoing a facelift in 2016, with a new format, as will other Hypersomnia Foundation social media platforms.

Every dollar given to the Hypersomnia Foundation ensures that this work continues and even expands. As an all-volunteer organization, the Hypersomnia Foundation has big plans for 2016, including increasing volunteer input, improving our means to keep you informed of the latest hypersomnia-related news, developing the Scientific and Corporate Advisory Boards, and building a research grants program.

With sincere thanks and gratitude,

The entire Board of the Hypersomnia Foundation

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The Hypersomnia Foundation Welcomes New Board Members

We are pleased to announce that Scot Hulshizer, Celia King, and Diane Powell have recently been elected to the Board of Directors of the Hypersomnia Foundation.

In addition to bringing unique strengths as the organization thrives and grows in both scope and depth, each new Board member has a loved one with hypersomnia. Over the coming months, we will be introducing you to Scot, Celia, and Diane. The Board is grateful to Jennifer Beard for her service in helping to launch the organization and is truly appreciative of her dedication and hard work on behalf of people everywhere with hypersomnia. The entire Board of Directors wishes Jennifer well in her future endeavors.

scot hulshizerScot Hulshizer joined the Hypersomnia Foundation’s Board of Directors as the Chief Financial Officer on August 19, 2015. Scot has held leadership roles at large companies as well as having been an investor and executive in several small businesses and entrepreneurial endeavors across the real estate, automotive, technology, and hospitality industries. He currently serves as the Director of Corporate Development for ADT at their corporate headquarters in Boca Raton, Florida. In addition to his professional endeavors, Scot serves as the Chair of the Scholarship Selection Committee for the Palm Beach chapter of Mensa and was formerly Chair of the Family Selection Committee for Habitat for Humanity in Texas. He earned his MBA from Kennesaw State University in 2007 while serving as Director of National Sales Operations for AT&T.

Scot first learned of hypersomnia as his wife, Danielle, struggled with a sleep disorder that disrupted her personal and professional life despite the best efforts of multiple neurologists and sleep specialists. She was one of the first patients to be diagnosed with this poorly understood condition by Dr. David Rye at Emory. Scot and Danielle have since provided support and encouragement for other individuals and families impacted by hypersomnia and were featured on the CNN show Vital Signs in 2015. By the way, in case you missed this show, you can watch it now. Just follow the link on our website at http://www.cnn.com/videos/intl_tv-shows/2015/04/15/spc-vital-signs-sleep-disorders-b.cnn.

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CNN Features Hypersomnia in Three Part Series

Set your DVRs, check it out live, or catch a sneak peak, but don’t miss this program on sleep and idiopathic hypersomnia on CNN!

Dr. Sanjay Gupta not only undergoes a Multiple Sleep Latency Test at Emory Sleep Lab, but also discusses idiopathic hypersomnia and its treatment with Dr. David Rye and Danielle Hulshizer. This episode of Vital Signs will air live on Saturday, April 25, 2015, at 3:30 PM EDT and again on Saturday, May 9, 2015, at 3:30 pm, EDT on CNN. In the meantime, you can watch the segments online by clicking on the following links.

PART 1: How important is a good night’s sleep?

PART 2: Tired all the time?

Posted in: Awareness, News, Press Coverage

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HF Offers First HF Conference Scholarship

The Board of Directors of the Hypersomnia Foundation is pleased to announce the First Hypersomnia Foundation Conference Scholarship.

This scholarship will cover the conference registration for one person to the Building Our Future Together conference to be held at the Emory Conference Center on July 18, 2015. Selection of the recipient will be by lottery.

If tight finances are keeping you from attending this year’s Hypersomnia Foundation Conference, please send a message to info@hypersomniafoundation.org with the subject line “Conference Scholarship.” Please include your name and email address. The deadline to submit requests for this scholarship is April 25, 2015. The winner will be announced on April 28, 2015.

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Submission to the FDA’s Regarding Hypersomnias

On September 24, 2013, the US Food and Drug Administration (FDA) held a public meeting to solicit information on the impact of narcolepsy on affected individuals’ daily lives and the effect of currently available medication on their disease symptoms.

A summary of that meeting, “The Voice of the Patient Report—Narcolepsy,” is available on the FDA’s web site.  After the meeting, the FDA asked for additional input as part of its Patient-Focused Drug Development Initiative. This initiative is designed to ensure that the FDA pays proper attention to developing drugs for conditions that affect Americans. On behalf of the Hypersomnia Foundation, Drs. David Rye and Lynn-Marie Trotti from Emory University submitted the following letter to the FDA highlighting the need for additional attention to, and clear unmet needs among patients with, hypersomnia but not classic Type 1 narcolepsy.

RE:  FDA  DOCKET# –  2013-N-0815

We are clinician scientists board certified both in Sleep Medicine and Neurology with a combined 30 years of clinical experience that includes a particular focus on narcolepsy and related disorders collectively referred to as the “central hypersomnias”.  We are well published in the area and regularly participate in the annual patient conferences of the Narcolepsy Network.  We join with our patients in thanking you for your effort to reach out for input regarding the disease state(s) and especially the unmet needs of the patients who we treat. Having viewed the webcast of the recent September 24th public meeting on narcolepsy patient-focused drug development, we would like to add our voice to those of others.

Excessive daytime sleepiness remains common and the socioeconomic burden to the individual, family, and society is large.  Unfortunately, while routine sleep laboratory testing for genuine narcolepsy with cataplexy is sensitive, it is becoming clear that it is highly nonspecific.  The electrodiagnostic criteria for narcolepsy, for example, are satisfied by 2.5-4.0% of the general population 1,2, and even higher proportions of patients with comorbid sleep apnea, Parkinson’s disease, and end-stage renal disease.  Narcolepsy with cataplexy is caused by loss of the wake-promoting excitatory peptide hypocretin and manifests as discontinuous wake and sleep, abrupt transitions from wake to sleep, restorative naps, and the overt expression/experience of dream sleep phenomena such as cataplexy. What it is not associated with is hypersomnia – i.e., a condition characterized by abnormally long or frequent periods, or abnormal depth, of sleep.  Narcolepsy with cataplexy affects 1 in 2,000-4,000 individuals, and is the prototypical sleep disorder which medical students and physicians are first introduced to, and how they learn sleep biology.  There is therefore a deep rooted propensity to approach and treat any complaint of sleepiness as a loss-of function problem.  Conventional psychostimulants, newer wake promoting agents, and drugs in development to treat the excessive daytime sleepiness ofnarcolepsy” are purposefully targeted to restore wake by way of enhancing neural pathways downstream from hypocretin.   In summary, a perfect storm is brewing for the overdiagnosis of “narcolepsy” and a real potential for the over prescribing of medications for its treatment.

With this background, we were not at all surprised to hear a number of presumed “narcolepsy” patients (and others at your April patient conference on Chronic Fatigue Syndrome) speak about the unmet clinical need that hypersomnia represents.  Despite feeling physically awake, we have heard innumerable stories of persistent cognitive problems and “brain fog” from hypersomnic patients prescribed conventional psychostimulants or wake promoting agents. Compelled by clinical intuition that these patients were not suffering from any loss in function (and finally brave enough to challenge a conventional wisdom that had even influenced our personal practice preferences for at least a decade), our team has recently shown, that a majority of patients suffering from hypersomnia do so because of an apparent gain in function in inhibitory GABAA receptor signaling due to a peptidergic somnogen3.  In this instance sleep is long, continuous, and unrefreshing, and followed by a transitional state of impaired consciousness termed “sleep drunkenness”.   Such a prolonged state of stupor that follows upon sleep has never been operationalized and its neural substrates remain ill-defined.  Thus, diagnostic means to differentiate the symptom of hypersomnia as part of, or distinct from, diagnoses such as narcolepsy without cataplexy, idiopathic hypersomnia, long sleeper syndrome, and depression and even chronic fatigue syndrome, and rational and effective treatments, have not been forthcoming.  The benzodiazepine antagonist flumazenil, which has little-to-no wake promoting actions in non-sleepy controls, reverses GABA enhancement in vitro, and normalized vigilance in seven of seven hypersomnic patients 3. Our serendipitous discovery that the macrolide antibiotic clarithromycin is also an antagonist at GABAA receptors, provided a rationale for its successful use in the central hypersomnias, where sustained improvements in vigilance were observed with off-label use 4, as well as in a double-blind, placebo-controlled, cross-over trial in 20 patients 5.

In summary, our experience in evaluating and treating nearly 500 patients with central hypersomnia would suggest that there is a well-defined group of genuine, hypocretin deficient, non-hypersomnic patients with narcolepsy who generally do quite well with the existing approved treatments.  The same can not be said of hypersomnics.   The prevalence remains ill-defined, but we are confident that it is greater than “rare” as stated in review articles and texts (we estimate a prevalence of at least ~ 1:800).  And, hypersomnia can be extraordinarily disabling.  In one-third of patients with hypersomnia, the magnitude of enhancement of GABA’s sleep-inducing effects is equivalent to: a) 5 mg of Versed®; b) a blood alcohol content of 0.10; and c) the psychomotor slowing that emerges after 30 hours of continuous wakefulness3.  We feel for these patients.  They are not simply “seized by sleep” as the narcoleptic with cataplexy, they are literally and figuratively consumed and transformed by it.  Many whom we have evaluated and treated are refractory to conventional wake promoting agents or experience intolerable side effects.  Strategies aimed at inhibiting sleep as opposed to promoting wake would appear more rational in that they would be targeted closer to the underlying pathophysiology.  In our hands such an approach to treatment continues to demonstrate remarkable and truly life altering results.

We hope that our perspective better informs the FDA in their future assessments of treatments being developed for narcolepsy versus hypersomnia.  Our ultimate desire is a more efficient means to diagnosis so that more rational and effective treatments can be instituted sooner, more knowledgeable about the risk-benefit ratios and cost.

References:

1.   Singh, M., Drake, C. L. & Roth, T. (2006). The prevalence of multiple sleep-onset REM periods in a population-based sample. Sleep 29, 890-5.

2.  Mignot, E., Lin, L., Finn, L., Lopes, C., Pluff, K., Sundstrom, M. L. & Young, T. (2006). Correlates of sleep-onset REM periods during the Multiple Sleep Latency Test in community adults.[see comment]. Brain129, 1609-23.

3.   Rye, D. B., Bliwise, D. L., Parker, K., Trotti, L. M., Saini, P., Fairley, J., Freeman, A., Garcia, P. S., Owens, M. J., Ritchie, J. C. & Jenkins, A. (2012). Modulation of vigilance in the primary hypersomnias by endogenous enhancement of GABAA receptors. Science Translational Medicine4, 161ra151.

4.   Trotti, L., Stout, A., Saini, P., Freeman, A., Jenkins, A., Garcia, P. & Rye, D. (2012).  Clarithromycin reduces sleepiness and improves vigilance in patients with central nervous system hypersomnias. Sleep35, A278.

5.   Trotti, L., Saini, S., Freeman, A., Bliwise, D., Jenkins, A., Garcia, P. & Rye, D. (2013). Clarithromycin for the treatment of hypersomnia: A randomized, double-blind, placebo-controlled, crossover trial. Sleep36, A248.

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The Hypersomnia Foundation’s 501 (c)(3) status has been approved!

The Hypersomnia Foundation received a letter from the Internal Revenue Service stating that we have met all of the requirements to be a charitable organization. That’s right. The IRS has officially approved the Hypersomnia Foundation’s 501(c)(3) status!

Not only are we exempt from paying federal income tax, but contributions made to the Hypersomnia Foundation by individuals and corporations are deductible under Code section 170. You will want to check with your tax advisor, but, basically, this means that any donations made to the Hypersomnia Foundation on or after January 21, 2014, are tax-deductible to the extent allowed by law.

The Hypersomnia Foundation Board members–Cat Rye, Cate Murray, and Jennifer Beard–extend deep gratitude for your ongoing support and enthusiasm. You make all of our hard work worth it every day. We could not have done this without YOU there supporting us and cheering us on every step of the way. The hypersomnia community now has an official charity created specifically to support YOU. Congratulations to everyone!  This is a big win for our community and for medical and scientific hypersomnia researchers.

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The Hypersomnia Foundation has submitted our 501(c)(3)!

The Hypersomnia Foundation Board members have been hard at work!  After countless hours of collaborative work, we have finally completed our 501(c)(3) application and submitted it to the IRS for approval.

One component of the 501(c)(3) application is called “Form 1023 Narrative of Activities”.  In the standard 501(c)(3) application process, this section is quite lengthy.  In fact, when we, the Board members completed that section, we had over 26 pages of narrative typed out.  We wrote at length, and in detail about all of our initiatives and made specific plans for implementing and carrying out each and every one.

After spending countless hours working on this, a new (and MUCH shorter) Form 1023-EZ was recently made available on the IRS website.  While Form 1023-EZ is likely to unleash large numbers of ill-prepared and poorly conceived nonprofits that would never have followed through with the filing of the standard Form 1023, the Hypersomnia Foundation feels strongly that we have done our due-diligence by taking our time to properly complete the standard version of Form 1023 before filing Form 1023-EZ.  We are happy we took the proper amount of time to consider, collaborate, and create comprehensive plans for all of the initiatives we will pursue now and in the future.  We have the best of both worlds!  A well laid out plan, and a quick projected approval time.

Once approved, The Hypersomnia Foundation will be able to officially accept tax deductible donations.  Our attorney has advised us that entities filing the new Form 1023-EZ are typically approved in a few weeks.  Wow!  As soon as we receive our approval status from the IRS, you will be the first to know!  The good news is that once we are approved, the approval is retroactive back to the date of our incorporation which was January 21, 2014.

This means that any donations made to the Hypersomnia Foundation on or after January 21, 2014, will be officially tax deductible once we are approved!

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