Clinical trials: Disorders of Excessive Somnolence
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
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.
Lumbar Disc Herniation, Obstructive Sleep Apnea Risk Management
Daytime vs Evening Rehabilitation in Lumbar Disc Herniation Patients at High Risk for Obstructive Sleep Apnea
Lumbar disc herniation is a common musculoskeletal condition that negatively affects quality of life, physical function, and daily activities.
- Trial name
- REHAB-TIME (NCT07522021)
- Testing
- Physiotherapy and Exercise Program
- Volunteers
- 60 people
- Sponsor
- Mardin Artuklu University
Narcolepsy
Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription
Patients will be followed up for max 18 months. Information on the Adverse Events and potential misuse or abuse of Xyrem ® will be collected.
- Trial name
- NCT00244465
- Where
- 41 sites in Austria, Belgium and 7 more
- Volunteers
- 750 people
- Sponsor
- UCB Pharma
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
Partial Epilepsy
Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy
Sleepiness and fatigue are the most common complaints of people with epilepsy and can have a negative impact on quality of life. Though unproven, these problems are often blamed on anti-seizure medications.
- Trial name
- NCT01190098
- Testing
- Lacosamide
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- The Cleveland Clinic
Major Depressive Disorder, Excessive Sleepiness
Safety and Tolerability of Single and Multiple Ascending Doses of GATE-101 in Normal Human Volunteers
To evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of GATE-101 in normal human volunteers
- Trial name
- NCT04618263
- Testing
- GATE-101
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Syndeio Biosciences, Inc
Narcolepsy
Risk of Narcolepsy Associated With Administration of H1N1 Vaccine
The goal of the study is to assess the risk of occurrence of narcolepsy following the administration of inactivated (AS03) adjuvanted A/H1N1 pandemic influenza vaccine in the province of Quebec, Canada, using different case…
- Trial name
- NCT01394614
- Testing
- A/H1N1 vaccine
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Long COVID, Long COVID-19
RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)
The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple…
- Conditions
- Long COVID, Long COVID-19, Hypersomnia
- Trial name
- NCT06404099
- Testing
- Modafinil, Solriamfetol
- Where
- United States
- Volunteers
- 361 people
- Sponsor
- Duke University
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
Myotonic Dystrophy
Efficacy and Safety of DHEA for Myotonic Dystrophy
To test the efficacy and safety of two doses of dehydroepiandrosterone (DHEA) in adults with myotonic dystrophy
- Trial name
- NCT00167609
- Testing
- dehydroepiandrosterone 100 and 400 mg
- Where
- 10 sites in France
- Volunteers
- 75 people
- Sponsor
- University of Versailles
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
Sleep Apnea Syndromes, Snoring
Effects From a Mandibular Repositioning Appliance in Patients With Obstructive Sleep Apnea and Snoring
The purpose of this study is to evaluate effects from a mandibular repositioning appliance on obstructive sleep apneas, symptoms, blood pressure and markers of stress, inflammation and cardiovascular health in patients with mild…
- Conditions
- Sleep Apnea Syndromes, Snoring, Disorders of Excessive Somnolence
- Trial name
- NCT00477009
- Testing
- Mandibular repositioning appliance, adjustable
- Where
- Sweden
- Volunteers
- 96 people
- Sponsor
- Umeå University
Narcolepsy
Observational Study of LUMRYZ in Narcolepsy
This is an observational study of LUMRYZ prescribed in clinical practice. Patients are asked if they would be willing to complete questionnaires over a 4-month period after starting LUMRYZ.
- Trial name
- REFRESH (NCT06792708)
- Testing
- LUMRYZ
- Where
- 12 sites in United States
- Volunteers
- 71 people
- Sponsor
- Avadel
Narcolepsy
Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or obstructive sleep apnea/hypopnea…
- Trial name
- NCT00214968
- Testing
- Modafinil
- Volunteers
- 92 people
- Sponsor
- Cephalon
Sleep Apnea, Obstructive, Diabetes Mellitus, Type 2
Obstructive Sleep Apnea (OSA), Sleepiness, and Activity in Diabetes Management
Daily physical activity is important to achieve glucose control in persons with type 2 diabetes. The purpose of this study is to explore if obstructive sleep apnea and its daytime symptom, excessive sleepiness, act as barriers to…
- Trial name
- OSA_DM (NCT00801892)
- Testing
- Continuous Positive Airway Pressure (CPAP)
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Eileen R. Chasens
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
Excessive Daytime Sleepiness, Narcolepsy
A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy
Histaminergic agents are known to be involved with the sleep/wake cycle. This compound is a histaminergic agent which therefore may improve alertness and awakeness in patients with excessive daytime sleepiness (EDS) associated…
- Trial name
- NCT01006122
- Testing
- PF-03654746
- Where
- 21 sites in United States
- Volunteers
- 95 people
- Sponsor
- Pfizer
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
Narcolepsy, Cataplexy
Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder
Up to 50% of Narcolepsy-cataplexy (NC) patients suffer from REM sleep behavior disorder (RBD), a parasomnia. A strong link was found between RBD and impulse control disorders (ICD) in Parkinson disease (PD) patients.
- Trial name
- NC-TCSP-IRMf (NCT03425214)
- Testing
- fMRI, Videopolysomnography, NC (narcolepsy-cataplexy)
- Where
- France
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- University Hospital, Clermont-Ferrand