Research Studies/Clinical Trials

If you are thinking about taking part in a research study, including a clinical trial, there’s a lot to consider. Check out our FAQs below, as well as our lists of Ongoing Research Studies and results from Past Research Studies. Please contact us at if you know of any additional studies or results, or if the recruitment status for a study has changed, etc… You may also be interested in our SomnusNooze articles about Research Studies.

Note: If you are interested in trying a clinical trial treatment that is not available in your country, a company like WEP Clinical may be able to help you access this treatment.

DISCLAIMER: This listing is provided merely for informational purposes. Listing a study on this site/web page does not mean that it has been independently evaluated by the Hypersomnia Foundation. The safety and scientific validity of a study listed here is the responsibility of the study sponsor and investigators, not the Hypersomnia Foundation. Before making any decision as to whether or not to participate in a particular research study, you should (1) know the risks and potential benefits of that research study, and (2) consult your own healthcare provider.

The Hypersomnia Foundation’s International Registry at CoRDS

Have IH or a related disorder? Be sure to participate in (and keep updating) the Hypersomnia Foundation’s registry at CoRDS (Coordination of Rare Diseases at Sanford). NOW RECRUITING people with IH and all related disorders INTERNATIONALLY! CLICK HERE for more information and to enroll or update. CoRDS is also listed at And check out some initial results from the registry: Self-Reported Sleep Inertia in the Hypersomnia Foundation Registry.

A Pharmacokinetic and Safety Study of TAK-925 (an orexin 2 receptor agonist) in Participants with IH (Sparkle 2002) and Narcolepsy (Sparkle 1501)

The SPARKLE studies are testing an investigational drug (TAK-925, an orexin 2 receptor agonist) to see if it could potentially be a safe and effective way to help increase wakefulness for people with idiopathic hypersomnia or narcolepsy. A study doctor and staff can explain to you in greater detail other requirements and eligibility criteria you would have to meet to participate in the study. The total amount of time you may be involved in the study is up to 43 days. You will be reimbursed for your time and travel.

SPARKLE 2002: Currently recruiting in the U.S., adults age 18-75 with IH (who first experienced symptoms between age 10-30): CLICK HERE to see if you qualify. For further info from, CLICK HERE.

SPARKLE 1501: Currently recruiting in the U.S., adults age 18-65 with narcolepsy (with or without cataplexy): CLICK HERE to see if you qualify. For further info from, CLICK HERE.

This is a follow-up to Takeda’s earlier studies: 1) “Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Patients with Narcolepsy” (CLICK HERE to read more); 2) “A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Patients with Narcolepsy” (CLICK HERE to read more).

Pregnancy and Medication Registries

NOW RECRUITING pregnant women. If you are taking (or plan to take) any medication while pregnant, we strongly encourage you to participate in Pregnancy Registries to help further knowledge about medication safety during pregnancy. You can find a list of these Pregnancy Registries in the U.S. HERE. For pregnancy registries in other countries, ask your doctor(s) to direct you (and then please share this information with the HF at ).

A Study of the Efficacy and Safety of JZP-258 in the Treatment of IH

Jazz Pharmaceuticals’ trial of JZP-258 (a low-sodium alternative for Xyrem): CLICK HERE. NOW RECRUITING adults age 18-75 with IH across the USA and Europe (over 40 study locations including Belgium, Czechia, Finland, Poland, and Spain). Similar study of the Efficacy and Safety of JZP-258 in Subjects with Narcolepsy with Cataplexy: CLICK HERE (recruitment complete).


Balance Therapeutics’ Study of Oral BTD-001 in Adults With IH (Arise2)

NOW RECRUITING adults age 18 to 70 with IH (including those currently on a stimulant regimen) across the USA (and Canada): Arise2 and Interested in helping find a new treatment option that may work for people with idiopathic hypersomnia? BTD-001 is a GABA-antagonist that may possibly work similarly to flumazenil. Answer a brief 10 question quiz to find a participating study center in your area. Study centers are currently only in the United States, but Balance Therapeutics is supporting Canadians with IH to screen and potentially enroll if they qualify. Canadian residents, please contact Nichole Baio via email () or phone at (650) 351-7677‬. Please note that the criteria for participation in Balance Therapeutics’ Arise2 study have been updated, and this quiz is new as of April 2019. So if you haven’t taken it yet, please do so now. More details about the Arise2 study can be found HERE.

Some preliminary results were reported at the 2019 World Sleep Congress. Read more HERE.

Pathophysiology of Narcolepsy and Idiopathic Hypersomnia: a Multimodal Neuroimaging Study

NOW RECRUITING people with IH and narcolepsy (no geographical restriction, but if participants come from another time zone, they will require some adaptation to the study time zone prior to beginning the study). The project is to investigate brain regions underlying narcolepsy (with or without cataplexy) and idiopathic hypersomnia. The study includes an MRI scan session and two (non-consecutive) overnight sleep sessions at the sleep laboratory at the Institut Universitaire de Gériatrie de Montréal Research Center on Queen Mar Road in Montreal, Canada. Inclusion criteria are (1) Diagnosis of idiopathic hypersomnia or narcolepsy with or without cataplexy; (2) Age of 18 or more. Exclusion criteria are (1) Other sleep disorders; (2) Neurological disorders or head trauma; (3) Psychiatric disorders or use of psychotropic drugs; (4) Pregnancy or breastfeeding; (5) Pacemaker or metallic prosthesis. Participants will receive Can$200 of compensation if they complete the full study. For travel costs (if required, for those from other provinces or countries), up to Can$150 in travel reimbursements can be provided. If interested, please contact Elizaveta Frolova, Research Coordinator, via email: .

Boston Children's Hospital

Pediatric Hypersomnia Screening Survey

NOW RECRUITING children with IH, narcolepsy, other sleep disorders, or normal healthy sleep in the U.S. Dr. Kiran Maski, pediatric neurologist and sleep medicine specialist at Boston Children’s Hospital, and a member of the Hypersomnia Foundation’s Medical Advisory Board, has developed a questionnaire that aims to improve screening for narcolepsy and idiopathic hypersomnia, with the goal of helping health care professionals identify hypersomnia symptoms quickly. Boston Children’s Hospital is looking for participants between the ages of 8-18 years who have been recently diagnosed (within 1 year) with narcolepsy or idiopathic hypersomnia (or who are awaiting diagnosis with sleep study testing) to answer an online questionnaire, which should take no more than 10-15 minutes. They are also looking for children to take the survey as a clinical control group, who 1) are healthy, medication free, and without sleep problems or 2) have any other type of diagnosed sleep disorder (insomnia, sleep apnea, restless leg, delayed sleep phase, etc.). As a token of appreciation, the researchers will provide a $10 gift card if you qualify and complete the survey. If you would like to learn more about the study or are interested in participating, please send an email to Neuro Sleep Research () or call 617-919-6212. More info HERE.

Emory University

Clarithromycin Mechanisms in Hypersomnia Syndromes

NOW RECRUITING adults age 18-45 with IH and narcolepsy type 2 at Emory University in Atlanta, GA, U.S.: CLICK HERE. “The purpose of this study is to evaluate a medication called clarithromycin for treating sleepiness in two related conditions, narcolepsy without cataplexy and idiopathic hypersomnia. Studies have shown that clarithromycin can reduce sleepiness, but researchers do not know how clarithromycin does this. This study will look at brain activity (on magnetic resonance imaging [MRI] and electroencephalogram [EEG] brainwaves), inflammation, bacteria living in the gut, and cerebrospinal fluid, to better understand how clarithromycin can reduce sleepiness. This study will recruit 92 participants who will be randomized to receive clarithromycin or a placebo for 14 days.”

Emory University

Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia

NOW RECRUITING adults with IH or NT2 (who are newly diagnosed and untreated) at Emory University in Atlanta, GA, U.S.: CLICK HERE. “This study will evaluate which medication works better to improve sleepiness. The researchers will also see which medication is better for other symptoms including difficulty waking up and difficulty thinking, as well as seeing which medication causes fewer side [effects]. Finally, this study will see if any information about patients (such as age or sleep study features) predicts responding better to one medication or the other.”

Transcranial Direct Current (tDCS) Stimulation Therapy for Central Hypersomnia Without Cataplexy

NOW RECRUITING adults age 18-70 with IH and narcolepsy type 2 at The Ohio State University: CLICK HERE. See also: A Pilot Study of tDCS Looks Promising for the Treatment of Idiopathic Hypersomnia.

Sodium Oxybate (Xyrem) for Treatment of Excessive Daytime Sleepiness due to IH

NOW RECRUITING adults age 18-60 with IH in FRANCE: CLICK HERE. This study, sponsored by the University Hospital in Montpellier, France, will evaluate the efficacy of sodium oxybate (marketed as Xyrem) on excessive daytime sleepiness in people with idiopathic hypersomnia.

Constitution of a Clinical, Neurophysiological and Biological Cohort for Chronic Sleep Disorders Responsible of Hypersomnolence (Somnobank)

NOW RECRUITING people with hypersomnias in France: CLICK HERE. University Hospital in Montpellier, France is looking for volunteers age 8 and older suffering from chronic sleep disorders. The creation of a Clinical, Neurophysiological and Biological Cohort will focus on collecting data on severity of symptoms and genetic testing of blood samples to better understand the pathophysiology of hypersomnolence. While cohorts of this type have aided the understanding of narcolepsy type 1, the pathophysiology of narcolepsy type 2 (NT2), idiopathic hypersomnia (IH) and Kleine-Levin syndrome (KLS) is still unknown, due to the small number of patients studied. The study is recruiting volunteers according to the following ratio: NT1 (33%), other central hypersomnias (NT2, IH, KLS, 33%), and hypersomnolence secondary to a neurological sleep or vigilance disorder (ADHD, RLS, parasomnias, 33%).

University Hospital Zurich

The Role of the Circadian System in Neurological Sleep-Wake Disorders

NOW RECRUITING adults age 18-35 with IH or narcolepsy type 1 (or who are healthy) at University Hospital Zurich: CLICK HERE.

Sleep Health Foundation

Newcastle, NSW, Australia Study of Alternative Therapies in Hypersomnia

NOW RECRUITING adults with IH in Australia. The Adult Sleep Laboratory in Newcastle, NSW, Australia, is looking for adult volunteers for a research study investigating the effectiveness of alternative therapies on sleep and daytime alertness in adults aged 18 years or older with a diagnosis of hypersomnia. Visit the Sleep Health Foundation website for more information and to see if you qualify.

University Hospital Bern

Validation of Non-Invasive Miniature Optical Sensors for Scoring Sleep Stages

NOW RECRUITING healthy adults and those with sleep wake disorders in Switzerland at University Hospital Bern: CLICK HERE.

Brigham and Women's Hospital

Evaluation of the Efficacy of Sodium Oxybate (Xyrem) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia

NOW RECRUITING adults with post-traumatic hypersomnias at Brigham and Women’s Hospital in Boston, MA, U.S.: CLICK HERE.

The Chinese University of Hong Kong

Hypersomnia in Major Depressive Disorder

NOW RECRUITING adults age 18-64 with major depression (with or without hypersomnolence) at The Chinese University of Hong Kong: CLICK HERE.


Importance of Sleep Deprivation in Differential Diagnosis of Primary Hypersomnia 

RECRUITMENT STATUS UNKNOWN – Was recruiting adults in France with a sleepiness evoking a primary hypersomnia (not yet diagnosed with a hypersomnia): CLICK HERE.

Additional Research Studies

CLICK HERE for additional research studies, including those for related disorders, from and similar international public clinical trials registries.

If you are thinking about taking part in a clinical trial or research study and would like to know more about what this means, check out the FAQs below. In addition, the Center for Information & Study on Clinical Research Participation has prepared a useful list of “Questions to Ask” before deciding whether to participate in a clinical trial. Also, we strongly recommend that you speak with the person responsible for the study (known as the primary investigator or PI) or the study coordinator about any questions you might have that are specific to their trial.

See also these Personal Journey Stories:

What is a clinical trial?
A clinical trial is a type of research study in which researchers test new ways to prevent, screen for, diagnose, or treat a disease. In these FAQ’s, we will discuss clinical trials that are investigating treatments for a disease or condition. In a clinical trial, new treatments (such as drugs, devices, or procedures) are tested, or existing treatments are tested in new combinations or for new uses. The purpose of a clinical trial is to determine if a treatment is safe and/or effective. Some trials also look at other outcomes, such as change in quality of life.

What is the difference between a clinical trial and a research study?
All clinical trials are research studies, but not all research studies are clinical trials. Research studies may be observational – they might simply watch a group of people who have been exposed to something to see if it causes disease in the future, or they might follow patients with a specific disorder over time. Clinical trials involve human beings. Other research studies may involve animals, basic research at the cellular level, or other types of research that don’t involve the testing of a treatment in people. New treatments are first tested in animals or in other ways before being tried in humans.

What is a study protocol?
The protocol is the plan of action for a clinical trial, and it is set up to answer a series of questions that the researchers developed. Study protocols typically outline:

  • The reason that the study is being performed
  • Who will take part in the study (the eligibility criteria)
  • How many participants will be needed
  • What the participants will be doing
  • The schedule of tests, procedures, or drugs and their dosages
  • How long the study will last
  • What the researchers will be measuring and what information will be gathered from participants

What is randomization or a randomized controlled trial?
Some trials test a single treatment in all participants. Others separate the participants into one or more groups and test the treatment against another drug or against a placebo (a substance that looks like the treatment being studied but that has no active ingredient). When participants are assigned to different treatments, it is important that this occurs without bias, which is why treatment assignments are done randomly. Randomization is essentially a coin toss to determine who will receive the treatment being studied and who will receive the placebo (sham treatment) or other treatment (active comparator). These groups are often known as arms of the study. The people who receive the treatment being studied are in the active arm, and the others are in the control arm. When there is no approved or available treatment for a condition, the active arm receives the treatment being studied, and the other group receives a placebo. When a treatment that is considered to be a standard of care for a condition, the active arm again receives the treatment being studied, but, in this case, the control group receives the standard treatment.  There are also variations in study design that allow each participant to receive both placebo and active drug for a defined period of time.  These studies are called “crossover” studies. In these types of studies, the order in which people receive the different treatments is determined randomly, and the responses participants have to each of the different treatments are compared.

What is meant by the term blinding?
In a blinded study (actually masking or masked is a better but infrequently used term), the participants, the researchers, or both do not know to which arm a given participant is assigned. When neither the participants nor the researchers know the assigned group, the study is said to be double-blind.  This helps minimize the chance that bias will affect the results of the study.

What is an Institutional Review Board?
An Institutional Review Board or IRB is a group of people (scientists, statisticians, and members of the general public) who review study protocols to ensure that participants are kept safe and treated ethically and that the benefits of participating in the study are proportionally higher than the risks. Academic medical centers (doctors or hospitals associated with universities or medical schools) typically have their own IRBs, but there are also commercial IRBs that charge a fee to review study protocols, which are subsequently and typically conducted outside of academic medical centers. Institutional Review Boards also review and approve consent documents used in each clinical trial.

What is meant by informed consent?
Informed consent is the process by which you learn about a given research study in which you might choose to participate. The study coordinator, the doctors or scientists involved in the study, or nurses will explain all aspects of a clinical trial to you in terms that you can understand. After talking with you, they will give you a printed version of this information, which you should carefully review. Once you are comfortable that you understand all of the information presented to you and have made the decision to take part in the study, you sign a consent form. This form is not binding, however. At any time before or throughout the study, you can stop taking part in the trial (that is, you can withdraw consent) without penalty to you.

Are there any safeguards other than informed consent that protect research participants?
The first round of safeguards involves the Institutional Review Board. In addition, the federal government regulates most clinical trials that take place in the United States through the Office of Human Subjects Research Protection and the Food and Drug Administration.  The research institution in which the study takes place – whether a university medical center, private hospital or doctor’s office, or some other setting – should also oversee the safety of the participants. Finally, each protocol should include ongoing plans for monitoring the data that are gathered in the trial and for tracking participants’ safety.

Why should I participate in a clinical trial?
People decide to take part in a clinical trial for any of a number of reasons. Most studies need healthy people to participate in trials early in the process to test the safety but not the effectiveness of a treatment. For others, perhaps there is currently no treatment for their medical condition or the available treatments are ineffective and they want to have a chance at being in the arm of the study that receives the new treatment. Some people participate in clinical trials for altruistic reasons—they simply want to help others with their condition. For example, a person with a disease might currently have their symptoms under good control with their current drug regimen, but a new treatment is being studied in a clinical trial. They might have to stop their current treatment to take part in the new study, but they do so with the intention of helping to make a new treatment available for others.

Who pays for clinical trials?
Pharmaceutical companies, academic medical centers, nonprofit organizations and foundations, the National Institutes of Health, the U.S. Department of Defense, the U.S. Department of Veterans Affairs, physicians, other health care providers, and other individuals can all sponsor clinical research.

How do I find out about what clinical trials are available?
Many clinical trials in the United States are registered at The Food and Drug Administration requires registration for all interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial (1) has one or more sites in the U.S; (2) involves a drug, biologic, or device that is manufactured in the US (or its territories); or (3) is conducted under an investigational new drug application or investigational device exemption. In addition, most medical journals now require, as a term of publication, that the clinical trial had been registered at a publicly available site such as  Be sure to explore research studies currently looking for participants with idiopathic hypersomnia, Kleine-Levin syndrome, and narcolepsy. It may also be helpful to use the more generic search term “hypersomnia.” Also, if you are interested in a clinical trial treatment that is not available where you live, a company like WEP Clinical may be able to help you access this treatment.



Below, please find results of research studies we have featured in the past. Please also see: Journal Article Summaries.

Once Nightly Formulation of Sodium Oxybate (FT218) for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy

RECRUITING COMPLETE as of December 2019: CLICK HERE. Phase 3 clinical trial of single-dose sodium oxybate by Avadel Pharmaceuticals (formerly Flamel, prior to 2017 merger). More info HERE.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Patients with Narcolepsy

RECRUITMENT COMPLETE, in Japan: CLICK HERE. This is a follow-up to Takeda’s earlier study: “Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Patients with Narcolepsy” (CLICK HERE to read more). TAK-925 is an orexin 2 receptor agonist.

Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)

RECRUITING COMPLETE: CLICK HERE. Axsome Therapeutics is enrolling people with narcolepsy with cataplexy (only) for a study of the efficacy of AXS-12 (reboxetine) for treatment of cataplexy and excessive daytime sleepiness. AXS-12 is an oral norepinephrine reuptake inhibitor (NRI).

A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy

RECRUITMENT COMPLETE, in Japan and S. Korea: CLICK HERE. The pharma company, Taisho, notes HERE that this drug is for central disorders of hypersomnolence.

Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

Theranexus THN102 (modafinil/flecanide combo). RECRUITMENT COMPLETE, in France: CLICK HERE. For more info: 1) First Clinical Study Completed on Effectiveness of Possible Narcolepsy Drug THN102. Flecainide is “an antiarrhythmic agent used in this instance at very low dosages and for its modulating effects on the glial connexins”; and 2) Hungary OKs Phase 2 Clinical Trial of Drug Candidate for Excessive Daytime Sleepiness in Parkinson’s.

The PATH Study: Psychosocial Adjunctive Treatment for Hypersomnia

RECRUITING COMPLETE as of August 2019: CLICK HERE for more information. The purpose of this study is to develop and test a new psychological treatment designed to improve psychosocial functioning in people with hypersomnia. Study results pending.

Umecrine Cognition’s Phase IIa Study of GR3027 in Patients with IH

In January, 2019, Umecrine Cognition announced their overall results from this Phase 2a Study. The primary study objectives were met in regard to safety and pharmacokinetics and also showed preliminary evidence of clinical efficacy. CLICK HERE to find out more about these results. CLICK HERE for information on the original study. See also: Umecrine Cognition Expands Study of New Medicine GR3027 to IH.

Survey Study on Autonomic Impairment in Adults with Idiopathic Hypersomnia (IH)

Dizzy? Having troubles with your bowels or bladder? Body temperature up? Blood pressure down? Heart rate up AND down? Any of this could be related to your IH.

In 2018, the HF promoted this survey study, whose results will be presented at the May 2019 AAN (American Academy of Neurology) Annual Meeting. The researchers found that people with IH reported extremely high levels of autonomic dysfunction, on par with other conditions of severe autonomic failure, like MSA (multiple system atrophy) and diabetes. The researchers also hope to have some follow up studies soon, with a more detailed exploration of the potential mechanisms involved. Read the full abstract HERE.

To read our original SomnusNooze article about this study, CLICK HERE.


Arise1 – Balance Therapeutics’ BTD-001

In 2015, Balance Therapeutics announced the launch of the first double-blind, placebo-controlled, crossover, multicenter study of a drug (BTD-001) for the treatment of idiopathic hypersomnia (IH) and type 2 narcolepsy (T2N) in adults. More than 20 study sites throughout the United States screened people with IH and T2N for enrollment. As of 2018, this study is no longer recruiting participants. CLICK HERE for more information.

Results as of December 2017: An open-label study of the efficacy, safety and tolerability of oral BTD-001 in adults with idiopathic hypersomnia or narcolepsy type 2.

As of June 2018, Balance Therapeutics has launched a follow-up phase 2 clinical trial, NOW RECRUITING adults with IH across the USAARISE2 and Some preliminary results were reported at the 2019 World Sleep Congress. Read more HERE.

BUNIHPPS – An Online Research Survey for Patients with Narcolepsy & IH

In 2015, a research team at Boston University developed BUNIHPPS — a survey research study for patients with narcolepsy and idiopathic hypersomnia. Also called the Boston University Narcolepsy and Idiopathic Hypersomnia Patient Perspectives Study, BUNIHPPS was an anonymous online survey forging into new frontiers by asking patients about their experiences with symptoms, the diagnostic process, and their attitudes and behaviors. Dr. William DeBassio, a pediatric neurologist, and Sara Kowalczyk, a doctoral student at Boston University, were the study investigators. For more information, CLICK HERE.


The TONES Study (Jazz Pharmaceuticals’ JZP-110)

In 2015, doctors began conducting the TONES medical research study of an investigational product (JZP-110) designed to treat sleepiness and to help adults stay awake. The researchers wanted to evaluate the product’s effectiveness against excessive sleepiness when taken once a day for 12 weeks. Participants had to have been diagnosed with narcolepsy and sleeping at least 6 hours a night. For further info, CLICK HERE.

See also updates about related research into JZP-110:

Health and Well-being in Those with and Without a Disorder of Daytime Sleepiness – A Research Survey from Australia

In 2015, Victoria University in Melbourne, Australia, commenced a study about the general health and well-being of people within three groups. The first group was those people with both narcolepsy and cataplexy. (Cataplexy is a sudden loss of muscle tone, often triggered by emotional arousal.) The second group was people with either narcolepsy-without-cataplexy or idiopathic hypersomnia. The third group had no disorders of excessive daytime sleepiness. This project was part of a PhD program by Samantha Gauci (under the supervision of Prof. Dorothy Bruck and Dr. Warwick Hosking). One question in the study was whether the presence of cataplexy in narcolepsy was associated with a different level of general health and well-being (and some symptoms such as pain and migraines).


Get SomnusNooze, our e-newsletter

Sign up to receive HF updates, news from the world of sleep research, first-person stories, and more.

You will receive and email from (please check your junk/spam folder if needed) to confirm your subscription to our newsletter through MailChimp. You are not subscribed until you confirm. Thank you for your interest in Hypersomnia Foundation!