Clinical trials: Hypersomnia, active
Idiopathic Hypersomnia
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).
- Trial name
- NCT07500090
- Testing
- HBS-301 tablet
- Where
- 42 sites in United States, Canada
- Volunteers
- 248 people
- Sponsor
- Harmony Biosciences Management, Inc.
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
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
Wakefulness Disorder, Narcolepsy
Hypersomnia in the Paediatric Population
This is a 36-month, multicentric, cross-sectional study involving a paediatric population aged 6 to 17 years. Three groups will be included: Group A: children from the general population with no complaints of sleepiness; Group B…
- Conditions
- Wakefulness Disorder, Narcolepsy, Idiopathic Hypersomnia
- Trial name
- SOMNO-PED (NCT07766343)
- Testing
- Sleepness and wakeness scale, Polysomnography, Actimetry
- Where
- France
- Volunteers
- 760 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Short Sleepers, Normal Sleepers
Homeostatic Regulation of Sleep in Short Sleepers
This single-center study targets adults with distinct sleep profiles, divided into three categories: natural short sleepers, characterized by a reduced nocturnal sleep duration; subjects with idiopathic hypersomnia (IH) followed…
- Conditions
- Short Sleepers, Normal Sleepers, Idiopathic Hypersomnia Patients
- Trial name
- HOMEOSHORT (NCT07584538)
- Testing
- Actigraphy, Polysomnographie (PSG 128), TILE test
- Where
- France
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
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
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
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, Narcolepsy Type 1 (NT 1)
A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia
The aim of this project is to learn about how a change in diet will affect sleepiness, quality of life and metabolic health in people living with narcolepsy and idiopathic hypersomnia.
- Conditions
- Idiopathic Hypersomnia, Narcolepsy Type 1 (NT 1), Narcolepsy Type 2 (NT2)
- Trial name
- COMPANION (NCT07006233)
- Testing
- Whole Food Ketogenic Diet, Whole Food Diet
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- University of Sydney
Sleep Disorder, Sleep Disorder Parasomnia
Mainz Register of Patients With Sleep Disorders
Prospective longitudinal observational registry study of all patients with sleep disorders treated in the Mainz Comprehensive Epilepsy and Sleep Medicine Center with the focus on the course of the disease and quality of life.
- Conditions
- Sleep Disorder, Sleep Disorder Parasomnia, Narcolepsy, Sleep Apnea
- Trial name
- MAINZ-SLEEPREG (NCT05321355)
- Testing
- Implantation of vagus nerve stimulation according to clinical indication
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- Johannes Gutenberg University Mainz
Periodic Leg Movements, Excessive, Sleep-Related
Effect of Acute Exercise on Sleep Patterns in Patients With PLMS, Using a Wearable Device, Compared With a Control Group ( SONEX )
The effects of chronic exercise on health promotion, improvement of quality of life, and reduction of the risk of developing chronic diseases such as obesity, diabetes mellitus, cardiovascular diseases, depression, and cancer are…
- Trial name
- SONEX (NCT07382206)
- Testing
- cardiopulmonary exercise test (CPET), Cardiopulmonary Exercise Test (CPET) - Twice
- Where
- Brazil
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Associação Fundo de Incentivo à Pesquisa
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.
Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization, Sleep Inertia
Association Between Slow Wave Activity and Sleep Inertia
Observational study: The goal of this observational study is to learn about the association between slow wave activity before awakening and post-awakening psychomotor vigilance task in time-fixed, 2-hour, simulated night naps in…
- Conditions
- Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization, Sleep Inertia, Night Shift Work
- Trial name
- NCT07409883
- Testing
- Nap intervention
- Where
- Thailand
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mahidol University
Narcolepsy, Idiopathic Hypersomnia
A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH
The purpose of this study is to evaluate the efficacy and safety of expanded Xywav dosing regimens in adult participants with narcolepsy or idiopathic hypersomnia (IH).
- Trial name
- XYRISE (NCT07625280)
- Testing
- Xywav
- Where
- 15 sites in United States
- Volunteers
- 120 people
- Sponsor
- Jazz Pharmaceuticals
Excessive Sleepiness, Shift-work Disorder
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and…
- Trial name
- NCT06568367
- Testing
- Solriamfetol 150 mg, Solriamfetol 300 mg
- Where
- 49 sites in United States, Canada
- Volunteers
- 520 people
- Sponsor
- Axsome Therapeutics, Inc.
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
- 33 sites in United States, Australia and 3 more
- Volunteers
- 500 people
- Sponsor
- Takeda
Idiopathic Hypersomnia
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets
- Trial name
- Vibrance-3 (NCT06843590)
- Testing
- ALKS 2680
- Where
- 50 sites in United States, Australia and 6 more
- Volunteers
- 126 people
- Sponsor
- Alkermes, Inc.
Idiopathic Hypersomnia
a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -Trial
Idiopathic hypersomnia (IH) is a chronic disabling disorder characterized by excessive daytime sleepiness (EDS), prolonged nighttime sleep and sleep inertia.
- Trial name
- HyperChrono (NCT06252571)
- Testing
- - Melatonin - Active light ttherapy
- Where
- France
- Volunteers
- 72 people
- Sponsor
- University Hospital, Strasbourg, France
Narcolepsy, Idiopathic Hypersomnia
Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their Treatments
This is an observational study evaluating patients diagnosed with narcolepsy or idiopathic hypersomnia that have been prescribed a new/different hypersomnia treatment.
- Trial name
- NCT05371483
- Testing
- 24-hour Ambulatory Blood Pressure Monitoring, Oculo-Cognitive Addition Test (OCAT)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Mayo Clinic
Idiopathic Hypersomnia
A Study of TAK-360 in Adults With Idiopathic Hypersomnia
Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night.
- Trial name
- NCT06812078
- Testing
- TAK-360
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 96 people
- Sponsor
- Takeda