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 treatment's safety and to understand its effects over time, with participant involvement lasting through the entire study period.

Researchers are studying the safety, tolerability, and lasting effects of ALKS 2680 tablets in adults with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This open-label, long-term extension study builds on previous ALKS 2680 parent studies and aims to understand how well the treatment works over time and how safe it is for participants living with these sleep disorders. Participants will take oral tablets of ALKS 2680 once daily, with doses ranging from 4 mg to 18 mg. The study is non-randomized and includes groups of people with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. Those joining the study may need to stop other narcolepsy medications before starting ALKS 2680 and continue taking ALKS 2680 throughout the trial. During the study, participants will be monitored for treatment side effects and changes in sleepiness using tests like the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale. Researchers will track adverse events for up to 100 weeks and evaluate changes in sleep latency and sleepiness over several months. The study supports close safety monitoring and long-term follow-up from the start in early 2025 until mid-2028.

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 HBS-301, a medication, in adults aged 18 years and older who have idiopathic hypersomnia (IH), a condition causing excessive daytime sleepiness (EDS), sleep inertia, and fatigue. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of HBS-301 in improving IH symptoms compared to a placebo. Participants will be randomly assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking, at least one hour before meals. The study includes a Screening/Baseline Period lasting up to 28 days, followed by an 8-week Double-blind Treatment Period. After this, participants may join an optional Open-label Extension lasting one year. A 30-day safety follow-up period will occur after the treatment phases. During the study, participants will undergo evaluations of IH symptoms, including EDS, sleep inertia, and fatigue. Researchers will monitor safety throughout the 16-month study duration, including the extension phase. Outcome measures will include symptom severity, cognitive complaints, quality of life, and work productivity. Pharmacokinetic assessments of the drug and its metabolites will also be performed. Participants are expected to maintain stable doses of certain medications and comply with any sleep apnea treatment throughout the study.

The trial investigates the WatchPAT (WP) device's 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 device's 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 drug's 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 if they get a lot of sleep at night. People with IH may struggle to wake up, feel tired despite naps, and experience difficulty focusing or completing daily tasks. This trial is designed to evaluate the safety, tolerability, and potential benefits of TAK-360, a drug that acts like orexin, a brain chemical that helps maintain wakefulness, in adults with IH. Participants in the study will be randomly assigned to receive either TAK-360 tablets or placebo tablets, which look the same but contain no active medicine, for a period of 4 weeks. This randomized, double-blind design means neither participants nor researchers will know who receives the active drug or placebo during the trial, helping to fairly assess TAK-360's effects. During the study, participants will be monitored for any treatment-related side effects up to 8 weeks. Researchers will measure changes in sleepiness using the Epworth Sleepiness Scale and changes in IH symptoms using the Idiopathic Hypersomnia Severity Scale at the start and after 4 weeks of treatment. The trial lasts several weeks, including follow-up, to understand how TAK-360 affects safety, wakefulness, and symptom severity in IH.

Narcolepsy Type 2 (NT2) is a lifelong condition that causes excessive daytime sleepiness, sudden sleep episodes, and difficulty staying awake, affecting daily activities like driving and working. This trial is studying TAK-360, a medicine that acts like orexin, a brain chemical that helps keep people awake. The study aims to evaluate the safety, tolerability, and proper dosage of TAK-360 in adults with NT2. Participants will be randomly assigned to receive either TAK-360 or a placebo tablet orally for 4 weeks. The placebo looks like TAK-360 but contains no active medicine. This randomized, double-blinded trial compares TAK-360 with placebo to understand its effects on wakefulness and safety in adults with NT2. During the study, researchers will monitor side effects and measure sleepiness using tests like the Epworth Sleepiness Scale and the Maintenance of Wakefulness Test at the start and after 4 weeks. Participants will be observed for up to 15 weeks to track any treatment-related adverse events. This trial helps determine how TAK-360 is tolerated and its impact on staying awake for adults with NT2.