Idiopathic Hypersomnia

Idiopathic hypersomnia IH is a rare, chronic disorder marked by excessive daytime sleepiness, long nighttime sleep, and difficulty waking up. It often begins in young adulthood and causes serious social, professional, and economic challenges, leading to accidents and reduced quality of life. There are currently no approved treatments for IH symptoms. This study aims to test a safe treatment combining evening melatonin and morning bright light therapy, which has been effective in related sleep disorders and may improve alertness and mood in IH patients. Participants will receive either an active therapy of one melatonin tablet each evening plus morning bright light therapy, or a placebo consisting of a placebo tablet and placebo light therapy, both over a period of 6 weeks. This randomized, triple-blind trial compares these two groups to evaluate the effects of this combined chronobiological treatment. The study is conducted by the University Hospital in Strasbourg, France. During the study, participants will be monitored and assessed for changes in their IH symptoms using the Idiopathic Hypersomnia Severity Scale at days 14 and 45. The study includes careful screening, adherence to treatment schedules, and safety checks. Participants will be followed throughout the 10 weeks of the study to evaluate treatment impact and tolerability, with all procedures designed to understand if this therapy improves daytime alertness and quality of life.

Researchers are conducting a long-term extension study to evaluate the safety, tolerability, and effectiveness of ORX750 in adults aged 18 to 65 years who have narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia. This study follows participants who completed a previous ORX750 clinical trial and focuses on providing ongoing information about the treatment over an extended period. Participants will receive oral ORX750 in an open-label format, grouped by their specific diagnosis narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia. The study does not involve randomization or blinding, allowing all participants to know they are receiving the study drug. The treatment and monitoring periods include assessments up to about 70 days for safety and roughly 63 days for measures of drug concentration and wakefulness. During the study, participants will undergo frequent evaluations including monitoring for adverse events, laboratory tests, vital signs, ECGs, and assessments for suicidal thoughts or behaviors. They will also complete tests measuring wakefulness and sleepiness levels. This ongoing observation aims to ensure the treatments safety and to understand its effects over time, with participant involvement lasting through the entire study period.

Researchers are evaluating the long-term safety, tolerability, and lasting effects of ALKS 2680 tablets in adults with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This study is an open-label extension designed to continue monitoring participants who completed earlier ALKS 2680 parent studies, focusing on treatment durability and adverse events over an extended period. Participants receive ALKS 2680 oral tablets in doses ranging from 4 mg to 18 mg once daily. The study includes groups with Narcolepsy Type 1, Narcolepsy Type 2, and Idiopathic Hypersomnia. Treatment effects and safety are observed for up to 100 weeks, with dosing adjusted as needed. The study follows a non-randomized, open-label design without blinding. During the study, participants undergo regular assessments including monitoring of treatment-emergent adverse events, measurement of sleep latency using the Maintenance of Wakefulness Test, and evaluation of daytime sleepiness via the Epworth Sleepiness Scale. The total participation duration extends up to approximately 100 weeks, with safety, tolerability, and treatment effects closely tracked throughout this period.

Researchers are evaluating how changes in diet affect sleepiness, quality of life, and metabolic health in adults living with narcolepsy and idiopathic hypersomnia. This trial focuses on two dietary approaches a whole-food ketogenic diet and a standard whole-food diet, aiming to provide additional lifestyle options beyond medication for managing symptoms. This area of research is new for hypersomnolence conditions but builds on evidence of safety and benefits in other chronic and neurological conditions. The study is a 12-week randomized controlled trial with two groups. All participants start with a three-week period consuming a standard whole-food diet. After this run-in, they are randomly assigned to either continue the standard whole-food diet or switch to a whole-food ketogenic diet that limits carbohydrates to 30-50 grams per day to achieve nutritional ketosis. Both diets focus on unprocessed or minimally processed foods, with the ketogenic diet targeting specific ketone levels monitored through blood and urine tests. Participants will be involved in dietary changes and monitored for feasibility, tolerability, and compliance throughout the 12 weeks. Assessments include measures of sleep quality and sleepiness, metabolic health markers, mood, quality of life surveys, and dietary adherence using ketone levels and sleep diaries. Data collection involves interviews and questionnaires to understand patient experiences and preferences. The study aims to assess whether these diet changes can be sustained and improve health outcomes alongside usual care.

Researchers are evaluating the efficacy and safety of HBS-301 in adults aged 18 years and older who have idiopathic hypersomnia IH, a condition marked by excessive daytime sleepiness EDS. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to better understand how HBS-301 affects symptoms of IH including sleep inertia, fatigue, and cognitive complaints. Participants will be assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking during an 8-week double-blind treatment period. Following this, there is an optional one-year open-label extension where all participants may receive HBS-301. The study begins with a screeningbaseline period lasting up to 28 days and concludes with 30 days of safety follow-up after treatment. During the trial, participants will undergo various assessments including the Epworth Sleepiness Scale to measure daytime sleepiness, the Idiopathic Hypersomnia Severity Scale, Sleep Inertia Questionnaire, and other patient-reported outcome measures. Researchers will monitor changes in fatigue, cognitive function, quality of life, work productivity, and side effects throughout the study and extension period. Total participation may last up to about 16 months including safety follow-up.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of HBS-301 in adults aged 18 years and older with narcolepsy. The study focuses on treating excessive daytime sleepiness EDS, cataplexy, sleepinesswakefulness, and fatigue in participants diagnosed with narcolepsy. Approximately 258 participants will be included in this trial. Participants will be randomly assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking. The study includes a ScreeningBaseline period lasting up to 28 days, followed by an 8-week Double-blind Treatment period. After this, participants may choose to enter a 1-year Open-label Extension period where they will receive HBS-301. Finally, a 30-day safety follow-up will monitor participants after treatment ends. Throughout the study, participants will undergo various assessments including evaluations of daytime sleepiness using the Epworth Sleepiness Scale, cataplexy frequency, wakefulness through the Maintenance of Wakefulness Test, fatigue levels, cognitive complaints, quality of life, and work productivity. Safety will be monitored by tracking adverse events and pharmacokinetic measurements. The total study participation may last up to approximately 16 months including all phases.

The trial investigates the WatchPAT WP devices ability to detect sleep disorders compared to the gold standard polysomnography PSG in patients suspected of sleep disorders. Participants include individuals referred for sleep studies or those with comorbidities related to central sleep apnea. The study is prospective and blinded, aiming to gather data on the WP devices performance during clinical sleep evaluations. Participants will spend one night in a clinical sleep laboratory where they will simultaneously wear the WP device with a finger probe and chest sensor while undergoing a full-night PSG recording with standard channels. The PSG data will be recorded and manually scored without access to WP data to maintain blinding, while the WP device data will be analyzed automatically. This design allows comparison between the WP device and PSG results. During the study night, demographic and medical information will be collected from participants or their medical charts. Researchers will assess the Apnea-Hypopnea Index AHI and sleep stages from one night of sleep as primary outcomes, with the Respiratory Disturbance Index RDI as a secondary outcome. The study involves a single overnight visit with no long-term follow-up, focusing on accurately measuring sleep disorder indicators through both methods.

Researchers are evaluating the safety, tolerability, and how the body processes a drug called ORX142 in healthy adults aged 18 to 80 years. This Phase 1 clinical trial includes several parts to study single and multiple doses, the effects of food on the drug, and tests in both younger and older adults, as well as in people who have been acutely sleep-deprived. The study aims to understand the drugs effects on excessive daytime sleepiness. Participants will receive ORX142 or placebo tablets in different parts of the study. Parts A, B, and C focus on single and multiple ascending doses in healthy adults, with Part B examining the food effect on the drug. Part D studies single doses in healthy older adults, while Part E tests the drug in acutely sleep-deprived healthy adults. The study uses a randomized, double-blind, placebo-controlled design. During the trial, participants will be closely monitored for side effects and treatment-emergent adverse events from enrollment until 13 days after discharge. Blood samples will be taken before and after dosing to measure drug levels and how the body processes it over time. Sleepiness will be assessed using tests like the Maintenance of Wakefulness Test and the Karolinska Sleepiness Scale in Part E. Overall participation duration varies depending on the part of the study involved.

Researchers are evaluating the safety, tolerability, and effects of ORX750 in adults with Narcolepsy Type 1 NT1, Narcolepsy Type 2 NT2, and Idiopathic Hypersomnia IH. These rare conditions cause excessive daytime sleepiness and affect daily activities such as school, work, and driving. The study aims to understand how ORX750, which mimics the brain protein orexin that helps maintain wakefulness, impacts sleepiness and other symptoms in these conditions. Participants will receive either ORX750 capsules or matching placebo capsules in a randomized, double-blind setup. The study assesses multiple groups those with NT1, NT2, and IH. The treatment and monitoring will occur over a period of up to 35 days, including evaluation of plasma drug levels and sleepiness measures. During the study, participants will undergo safety assessments including monitoring for adverse events, laboratory tests, vital signs, ECGs, and suicidal ideation screening up to day 35. Researchers will also measure sleepiness using the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale. The total study duration for each participant is about five weeks, with careful observation of how the body processes ORX750 and its effects on daytime alertness.

Idiopathic Hypersomnia IH is a condition where adults feel extremely sleepy during the day, especially in the morning, even after sleeping a lot at night. This condition can cause difficulty waking up, trouble focusing, and symptoms like dizziness. Researchers are studying TAK-360, a drug that acts like orexin, a brain chemical that helps keep people awake. The study aims to understand how safe and tolerable TAK-360 is for adults with IH and to find the right dose to help with wakefulness. Participants in the study will be randomly assigned to receive either TAK-360 tablets or placebo tablets that look the same but contain no active medicine. Both treatments will be taken orally for 4 weeks. The study uses a double-blind design, meaning neither participants nor researchers know who receives the drug or placebo, to fairly evaluate the effects of TAK-360. During the study, participants will be monitored for safety and side effects up to 8 weeks. Researchers will measure changes in daytime sleepiness using the Epworth Sleepiness Scale and symptoms using the Idiopathic Hypersomnia Severity Scale at the start and after 4 weeks. The trial will also track any treatment-emergent adverse events. The total participation time may include screening, treatment, and follow-up assessments over several weeks.