Clinical trials: Narcolepsy and Hypersomnia
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, 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
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.
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
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
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 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, Idiopathic Hypersomnia
Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence
In humans, selective loss of orexin neurons is responsible for type 1 narcolepsy (NT1), or narcolepsy with cataplexy, or orexin deficiency syndrome.
- Conditions
- Narcolepsy, Idiopathic Hypersomnia, Cataplexy
- Trial name
- MRM-OREX (NCT05615584)
- Testing
- Quantitative mass spectrometry assay
- Where
- France
- Volunteers
- 117 people
- Sponsor
- University Hospital, Montpellier
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
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
Narcolepsy, Hypersomnia
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies
The project will improve scientific knowledge regarding a recent law applying potentially to every french driver. It will give for the first time an indication on the impact of alerting treatments on driving risks.
- Trial name
- AUTOSOP (NCT00916253)
- Testing
- Modafinil
- Where
- 2 sites in France
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University Hospital, Bordeaux
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, 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
Improving Social Relationships for Adolescents With Central Disorders of Hypersomnolence
The goal of this study is to test a web-based psychoeducational resource for adolescents with central disorders of hypersomnolence and their families.
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- NCT06251063
- Testing
- Web-based psychoeducational resource
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Boston Children's Hospital
Narcolepsy Type 1, Hypersomnia
Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy
This study intends to examine the utility of a home-use EEG-based sleep monitor for the diagnosis and evaluation of disorders of excessive sleepiness, specifically the neurological disorder Narcolepsy Type 1.
- Conditions
- Narcolepsy Type 1, Hypersomnia, Sleep Disorder
- Trial name
- NCT06531876
- Testing
- Dreem 3S recording
- Where
- 4 sites in United States
- Volunteers
- 78 people
- Sponsor
- Beacon Biosignals
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 Type 1, Hypersomnolence
Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions
Mind wandering is a state in which attention turns away from the external environment or current task to focus on internal thoughts (past experiences, future events, planned actions...).
- Conditions
- Narcolepsy Type 1, Hypersomnolence, Idiopathic Hypersomnia
- Trial name
- NARCOWANDERING (NCT06457945)
- Testing
- ASRT, Questionnaires, Electrophysiological recordings
- Where
- France
- Volunteers
- 180 people
- Sponsor
- Hospices Civils de Lyon
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
Hypersomnia, Narcolepsy
Feasibility Study of At-Home EEG Monitoring for Hypersomnia
The central hypothesis is that home EEG monitoring (Dream 3 wearable) can be feasibly utilized for data capture of continuous sleep and wake measurements for the diagnostic evaluation and treatment monitoring of hypersomnia.
- Trial name
- NCT05627388
- Testing
- Dreem 3 System At-Home Monitoring
- Volunteers
- healthy volunteers welcome
- Sponsor
- Kaiser Permanente
Narcolepsy Type 1, Hypersomnia
A Pilot Observational Study to Assess the Ability of Continuous 'Home' EEG to Accurately Diagnose Narcolepsy and Demonstrate Response to Treatment
The goal of this pilot observational study is to assess the ability of continuous 'home' EEG to accurately diagnose Narcolepsy in children and young people with hypersomnia.
- Trial name
- NCT05983731
- Volunteers
- 60 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust