Clinical trials: Primary Hypersomnia
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
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Idiopathic Hypersomnia
A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.
- Trial name
- ARISE2 (NCT03542851)
- Testing
- Pentetrazol (PTZ)
- Where
- 32 sites in United States
- Volunteers
- 80 people
- Sponsor
- Balance Therapeutics
Hypersomnia, Idiopathic Hypersomnia
Clarithromycin for the Treatment of Hypersomnia
The term 'hypersomnia' describes a group of symptoms that includes severe daytime sleepiness and sleeping long periods of time (more than 10 hours per night).
- Conditions
- Hypersomnia, Idiopathic Hypersomnia, Narcolepsy
- Trial name
- NCT01146600
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Lynn Marie Trotti
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, Narcolepsy Without Cataplexy
Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
For diseases that cause excessive daytime sleepiness (such as narcolepsy and idiopathic hypersomnia), there are several medications that can be used to treat sleepiness.
- Trial name
- NCT03772314
- Testing
- Modafinil, Amphetamine-Dextroamphetamine
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Emory University
Hypersomnolence
Sleep/Wake State Assessment with Non-invasive Earbuds
This study is a within subject's assessment of whether a novel wearable technology, NextSense electroencephalography earbuds (EEGBuds), is able to detect differences in onset to sleep from wake versus in-laboratory, gold-standard…
- Trial name
- NCT05066009
- Testing
- NextSense EEG-enabled earbuds, Ellcie Healthy eyeglasses, Drug Holiday
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Emory University
Shift Work
Effects of Operational Naps on Blood Pressure and Performance Among Night Shift Workers
Night shift work schedules disrupt sleep and have a negative impact on cardiovascular health. Most who work in public safety occupations and in healthcare work night shifts.
- Trial name
- EONN (NCT07217769)
- Testing
- No-nap, 15-min nap, 30-min nap
- Where
- United States
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
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
Narcolepsy 1, Idiopathic Hypersomnia
The Role of the Circadian System in Neurological Sleep-wake Disorders
The aim of this study is to investigate the role of the circadian system in patients with neurologic sleep-wake disorders. Therefore, overnight sleep will be distributed over 30 hours into repetitive sleep-wake cycles (poly-nap…
- Trial name
- PNP (NCT03356938)
- Testing
- Sleep restriction, Sleep deprivation
- Where
- Switzerland
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Esther Werth
Idiopathic Hypersomnia, POTS - Postural Orthostatic Tachycardia Syndrome
Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients With Postural Tachycardia Syndrome
The investigators hope to learn if low sodium oxybate (LXB) is an effective treatment for symptoms of idiopathic hypersomnia (IH) and postural tachycardia syndrome (POTS).
- Trial name
- NCT07077278
- Testing
- Low sodium oxybate (LXB)
- Volunteers
- 25 people
- Sponsor
- Stanford University
Hypersomnia, Idiopathic
Idiopathic Hypersomnia
Idiopathic hypersomnia (IH) is characterized by non-restoring night-time sleep, excessive daytime sleepiness, sleep inertia, impaired cognitive functioning and autonomic symptoms.
- Trial name
- IDAHO (NCT05150977)
- Testing
- Polysomnography
- Where
- Sweden
- Volunteers
- 69 people
- Sponsor
- Uppsala University
Obstructive Sleep Apnea (OSA), Insomnia
Validating the Use of a Subjectively Reported Sleep Vital Sign
Sleep disorders are commonly under-recognized in the primary care setting and available screening tools are often are limited. The study inestigators hypothesize that the use of a novel subjective sleep vital sign (VS) will…
- Conditions
- Obstructive Sleep Apnea (OSA), Insomnia, Restless Leg Syndrome (RLS), Hypersomnia Type; Sleep Disorder
- Trial name
- SVS (NCT03018912)
- Testing
- Sleep VS
- Where
- United States
- Volunteers
- 1,260 people, healthy volunteers welcome
- Sponsor
- Kaiser Permanente
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
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
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
Narcolepsy, Idiopathic Hypersomnia
Anesthetic Management of Patients With Chronic Sleep Disorders
The aim of this study is to describe and compare the anaesthesia history and possible problems encountered in 3 groups of patients with 3 chronic sleep diseases: narcolepsy, idiopathic hypersomnia, and restless legs syndrome…
- Conditions
- Narcolepsy, Idiopathic Hypersomnia, Restless Legs Syndrome
- Trial name
- ANEST-SLEEP (NCT04827329)
- Testing
- Questionnaire
- Where
- France
- Volunteers
- 700 people
- Sponsor
- University Hospital, Montpellier
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
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.
Narcolepsy, Social Cognition
Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia
Narcolepsy is a chronic disabling neurologic disorder mainly characterised by excessive daytime sleepiness. Type 1 narcolepsy is associated with a deficit of hypocretin in the cerebrospinal fluid responsible for the cataplexy…
- Trial name
- COGNAR (NCT05773872)
- Testing
- Questionary
- Where
- France
- Volunteers
- 75 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens