Clinical trials: Disorders of Excessive Somnolence
Sleep Disorder
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness
The main purpose of this study is to evaluate the safety and tolerability of the drug ABT-652 given once daily to people with excessive daytime sleepiness.
- Trial name
- NCT01124851
- Testing
- ABT-652
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Abbott
Narcolepsy, Cataplexy
Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia
Autonomic nervous system dysfunction has been described in narcolepsy with cataplexy affecting the sympathetic function. In this study the investigators analyzed whether altered diurnal and nocturnal cardiovascular control is…
- Trial name
- NCT02913651
- Testing
- Polysomnography
- Where
- France
- Volunteers
- 33 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Sleep
The Effect of Acupressure on the Sleep Quality and Daytime Sleepiness
This randomized controlled trial evaluates the effect of acupressure application on nurses' sleep quality and daytime sleepiness providing care in surgical clinics.
- Trial name
- NCT04800939
- Testing
- Acupressure, Plasebo acupressure
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Mersin University
Narcolepsy 1, Kleine-Levin Syndrome
Microglial Activation in Narcolepsy Type 1 and Kleine-Levin Syndrome: Positron Emission Tomography (PET) Study in [18F] DPA-714
Type 1 narcolepsy (NT1) is a chronic sleep disorder caused by the selective and irreversible loss of neurons from the hypothalamus, which synthesizes a neurotransmitter: hypocretin (Hcrt) / orexin.
- Trial name
- NARCOGLIE (NCT03754348)
- Testing
- PET scan with tracer injection [18F] DPA-714
- Where
- France
- Volunteers
- 78 people
- Sponsor
- University Hospital, Montpellier
Narcolepsy
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg…
- Trial name
- NCT02821715
- Testing
- THN102 300/3, THN102 300/27
- Where
- 8 sites in Belgium, France
- Volunteers
- 51 people
- Sponsor
- Theranexus
End Stage Renal Disease
Effects of Hemodialysis on the Sleep/Wake Cycle
The purpose of this study is to test a novel application of an existing treatment - using col dialysate (often used to treat hypotension) as opposed to warm dialysate (standard treatment) during hemodialysis for its ability to…
- Trial name
- NCT00460863
- Testing
- using cool versus warm dialysate during hemodialysis
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Emory University
Hypersomnia, Narcolepsy
Sleep Disorders of Patients With Diseases of the Nervous System
The purpose of this study is to assist training doctors about different diseases of the nervous system affecting sleep. Patients selected to participate in this study will have any of a variety of sleep disorders.
- Conditions
- Hypersomnia, Narcolepsy, Nervous System Disease, Sleep Disorder
- Trial name
- NCT00001664
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
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 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, Cataplexy
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- Trial name
- SYMPHONY (NCT05059223)
- Testing
- AXS-12 (reboxetine)
- Where
- 50 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Axsome Therapeutics, Inc.
Idiopathic Hypersomnia
A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adult participants with idiopathic hypersomnia (IH).
- Trial name
- NCT04091438
- Testing
- TAK-925
- Where
- 22 sites in United States, Japan
- Volunteers
- 28 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
CLARITY (Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol) is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial in patients with major…
- Trial name
- CLARITY (NCT07484217)
- Testing
- Solriamfetol 150 MG
- Where
- 40 sites in United States
- Volunteers
- 508 people
- Sponsor
- Axsome Therapeutics, 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
Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy
The purpose of this study is to assess the effectiveness and safety of the drug GSK189254 in treating patients with narcolepsy.
- Trial name
- NCT00366080
- Testing
- GSK189254
- Where
- 14 sites in Austria, Finland and 4 more
- Volunteers
- 69 people
- Sponsor
- GlaxoSmithKline
Narcolepsy, Excessive Sleepiness
Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy
This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to narcolepsy.
- Trial name
- NCT02806908
- Testing
- JZP-110
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- Jazz Pharmaceuticals
Sleep, Relaxation
Sleep and Morning Wellbeing Study
The study will be a prospective randomized, controlled clinical study. There will be interventional treatment for a total of 30 days. The subjects will complete questionnaires throughout the study at pre-specified timepoints.
- Conditions
- Sleep, Relaxation, Stress, Daytime Sleepiness
- Trial name
- NCT07311434
- Testing
- Sleep Supplement
- Where
- United States
- Volunteers
- 331 people, healthy volunteers welcome
- Sponsor
- Athletic Greens International
Narcolepsy Type 1
Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 Narcolepsy
This study is part of the research on type 1 narcolepsy, a neurological pathology affecting mostly young subjects. The only biomarker currently available is the hypocretin assay, which shows a level below 110 pg/mL.
- Trial name
- NARCO7T (NCT05967832)
- Testing
- 7T MRI
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Assistance Publique Hopitaux De Marseille
Restless Legs Syndrome, Insomnia
Restless Legs Syndrome Exercise Intervention
A pilot study of an aerobic exercise intervention to moderate symptoms and improve sleep quality among patients with Restless Legs Syndrome (RLS).
- Trial name
- NCT00258492
- Testing
- Aerobic exercise
- Volunteers
- 30 people
- Sponsor
- Northeastern Ohio Universities College of Medicine
Idiopathic Hypersomnia, Narcolepsy Without Cataplexy
A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2
This is a randomized, placebo-controlled, double-blind, multiple cohort, fixed-dose multiple crossover, dose-finding study of oral BTD-001 in adult patients with IH or Narcolepsy without cataplexy (Type 2).
- Trial name
- NCT02512588
- Testing
- BTD-001
- Where
- 23 sites in United States
- Volunteers
- 120 people
- Sponsor
- Balance Therapeutics
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