Clinical trials: Primary Hypersomnia
Idiopathic Hypersomnia, Narcolepsy
A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy
This study will assess the safety and efficacy of JZP258 (XYWAV) on sleepiness, polysomnography, and functional outcomes in patients with idiopathic hypersomnia (IH) or narcolepsy.
- Trial name
- NCT05875974
- Testing
- JZP258 (XYWAV)
- Where
- 32 sites in United States, Canada
- Volunteers
- 199 people
- Sponsor
- Jazz Pharmaceuticals
Idiopathic Hypersomnia
Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.
This Phase II clinical trial is a monocenter, double-blind, randomized, placebo-controlled study aimed at evaluate the efficacy and safety of solriamfetol from 75 to 300 mg per day in IH patients.
- Trial name
- SOLR-IH (NCT06590662)
- Testing
- Solriamfetol
- Where
- France
- Volunteers
- 60 people
- Sponsor
- University Hospital, Montpellier
Narcolepsy Type 1, Idiopathic Hypersomnia
Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic Hypersomnia
Links between sleep and food intake are manyfold. In healthy individuals, sleep deprivation promotes obesity by stimulating food intake of high glycemic index (GI) foods. Conversely, high GI foods induce sleepiness.
- Trial name
- NARCOFOOD (NCT06484348)
- Testing
- Monitoring of eating behaviors, Monitoring of sleep/wake rhythm, Measure of nocturnal sleep parameters
- Where
- 2 sites in France
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Idiopathic Hypersomnia
Local Sleep in Idiopathic Hypersomnia
Idiopathic hypersomnia (IH) is a rare and poorly studied disease characterized by excessive daytime sleepiness different from that of narcolepsy (sleep drunkness non-recuperative naps and nocturnal blackout).
- Trial name
- SL-HIP (NCT06153615)
- Testing
- EEG (64 electrodes), Cognitive task (SART), Pupillometry and eye tracking
- Where
- France
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Narcolepsy Type 1, Narcolepsy Type 2
A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness [EDS]).
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- CRYSTAL-1 (NCT06752668)
- Testing
- ORX750
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 248 people
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Idiopathic Hypersomnia, Excessive Daytime Sleepiness
A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia
The primary objective of this study is to assess the long-term safety and effectiveness of pitolisant in patients with idiopathic hypersomnia (IH) who completed the Double-Blind Randomized Withdrawal Phase of study HBS-101-CL-010.
- Trial name
- NCT05458128
- Testing
- Pitolisant
- Where
- 32 sites in United States
- Volunteers
- 119 people
- Sponsor
- Harmony Biosciences Management, Inc.
Idiopathic Hypersomnia
A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.
- Trial name
- NCT03533114
- Testing
- JZP-258
- Where
- 63 sites in United States, Belgium and 6 more
- Volunteers
- 154 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy Type 1, Narcolepsy Type 2
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS…
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- NCT06767683
- Testing
- ALKS 2680, 4mg, ALKS 2680, 6mg, ALKS 2680, 8mg
- Where
- 50 sites in United States, Australia and 6 more
- Volunteers
- 786 people
- Sponsor
- Alkermes, Inc.
Major Depression, Sleep Inertia
Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task
The study population comprises three groups of 30 analyzable participants: Patients with sleep inertia and Major Depressive Disorder, patients with Major Depressive Disorder but without sleep inertia, and controls without mood…
- Trial name
- IN-DEP (NCT06732284)
- Testing
- Psychomotor vigilance task, Video-polysomnography, Sleep and activity monitoring
- Where
- France
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Idiopathic Hypersomnia
Low Sodium Oxybate in Patients With Idiopathic Hypersomnia
Low sodium oxybate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic hypersomnia.
- Trial name
- NCT05837091
- Testing
- Low Sodium Oxybate, 24-hour polysomnography, Nextsense EEG earbuds
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Mayo Clinic
Idiopathic Hypersomnia, Mood Disorder
Psychiatric Co-morbidities and Socio-demographic Characteristics in Patients With Idiopathic Hypersomnia
This is a study of only patients with idiopathic hypersomnia. It is a rare and still poorly understood pathology. In clinical practice, we have found that the treatment and care offered were not always effective.
- Conditions
- Idiopathic Hypersomnia, Mood Disorder, Bipolar Disorder
- Trial name
- HYPERSOMNPSY (NCT05778721)
- Testing
- respond to questionnaires by telephone
- Where
- France
- Volunteers
- 22 people
- Sponsor
- University Hospital, Toulouse
Narcolepsy, Idiopathic Hypersomnia
International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study
Swiss Primary Hypersomnolence and Narcolepsy Cohort Study (SPHYNCS) is a cohort study on disease presentation and long-term course with an exploratory approach to detect biomarkers.
- Conditions
- Narcolepsy, Idiopathic Hypersomnia, Hypersomnolence Disorder
- Trial name
- iSPHYNCS (NCT04330963)
- Where
- Switzerland
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Idiopathic Hypersomnia
Sodium Oxybate in Idiopathic Hypersomnia
this study evaluates of the efficacy of sodium oxybate on excessive daytime sleepiness using Epworth sleepiness scale over 8 weeks compared to placebo
- Trial name
- SODHI (NCT03597555)
- Testing
- Sodium Oxybate Oral Solution 500 MG/ML
- Where
- France
- Volunteers
- 48 people
- Sponsor
- University Hospital, Montpellier
Narcolepsy Without Cataplexy, Idiopathic Hypersomnia
Clarithromycin Mechanisms in Hypersomnia Syndromes
The purpose of this study is to evaluate a medication called clarithromycin for treating sleepiness in narcolepsy and idiopathic hypersomnia.
- Conditions
- Narcolepsy Without Cataplexy, Idiopathic Hypersomnia, Narcolepsy With Cataplexy
- Trial name
- NCT04026958
- Testing
- Clarithromycin
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- Emory University
Narcolepsy Type 1, Narcolepsy Type 2
A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2)…
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- NCT07096674
- Testing
- ORX750
- Where
- 24 sites in United States, Canada and 2 more
- Volunteers
- 90 people
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Idiopathic Hypersomnia, Narcolepsy Type 1
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Central hypersomnia conditions are a group of sleeping disorders where the brain has trouble keeping a person awake during the day (called excessive daytime sleepiness or EDS).
- Conditions
- Idiopathic Hypersomnia, Narcolepsy Type 1, Narcolepsy Type 2
- Trial name
- NCT07646678
- Testing
- TAK-360
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 500 people
- Sponsor
- Takeda
Major Depressive Disorder, Primary Hypersomnia
Neurophysiologic Correlates of Hypersomnia
The goal of this project is to examine the neurophysiology of hypersomnia during sleep and wakefulness, to identify biomarkers for excessive sleepiness in neuropsychiatric disorders, and pilot acoustical slow wave induction…
- Conditions
- Major Depressive Disorder, Primary Hypersomnia, Bipolar Disorder, Narcolepsy
- Trial name
- NCT01719315
- Testing
- Acoustical slow wave induction
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Idiopathic Hypersomnia
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in participants with idiopathic hypersomnia (IH) age ≥18 years.
- Trial name
- NCT05156047
- Testing
- Open-label Pitolisant, Double-blind Pitolisant
- Where
- 58 sites in United States
- Volunteers
- 214 people
- Sponsor
- Harmony Biosciences Management, Inc.
Sleep Deprivation, Athletic Performance
Strategic Daytime Napping Enhances Agility and Lowers Perceived Exertion But Does Not Improve Fatigue Resistance in Adolescent Soccer Players
Background Daytime napping is increasingly incorporated into athletic recovery routines to manage sleepiness and support alertness.
- Conditions
- Sleep Deprivation, Athletic Performance, Fatigue
- Trial name
- NCT07314645
- Testing
- Pro Agility Test, Repeated-Sprint Ability (RSA) Test, Rate of Perceived Exertion (RPE)
- Where
- Turkey (Türkiye)
- Volunteers
- 16 people
- Sponsor
- Uludag University
Chronic Insomnia, Sleep Deprivation
Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia
This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders.
- Conditions
- Chronic Insomnia, Sleep Deprivation, REM Behavior Disorder, REM Sleep Behavior Disorder
- Trial name
- PSHW (NCT06644573)
- Testing
- PROSOMNIA Sleep Therapy™ (PSTx), Anesthesia-Induced Sleep Therapy, Diprivan (propofol), Astra-Zeneca
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Nyree Penn