Clinical trials: Excessive Daytime Somnolence
Narcolepsy Type 1, Hypnagogic Hallucinations
Imagery Control Therapy and Lucid Dreaming for REM-Related Symptoms in Narcolepsy
This randomized controlled trial evaluated the efficacy of a cognitive behavioral intervention based on lucid dreaming training and imagery control therapy for reducing REM-related symptoms in patients with narcolepsy type 1.
- Conditions
- Narcolepsy Type 1, Hypnagogic Hallucinations, Sleep Paralysis, REM Sleep Intrusion Symptoms
- Trial name
- ICLDR-NAR Tria (NCT07609537)
- Testing
- Cognitive Behavioral Therapy for Narcolepsy (CBT-NAR) With Lucid Dreaming and Imagery Control Therapy, Sleep Hygiene Education and Structured Clinical Follow-up
- Where
- Colombia
- Volunteers
- 98 people
- Sponsor
- Institute of Behavioral Sleep Medicine, Colombia
HIV Infections, Frailty
Sleep Quality and Frailty Among People Living With HIV
With effective antiretroviral therapy (ART), people living with HIV (PLWH) are living longer and are increasingly experiencing aging-related conditions such as frailty and sleep problems.
- Conditions
- HIV Infections, Frailty, Sleep Quality, Oral Frailty
- Trial name
- NCT07880054
- Testing
- No intervention (observational assessments)
- Where
- Taiwan
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- National Sun Yat-sen University
Excessive Daytime Sleepiness, Disorders of Excessive Somnolence
Feasibility and Acceptability of a 6-Week Myofunctional and Physical Activity Program for University Students With Excessive Daytime Sleepiness
The aim of this clinical trial is to examine the feasibility, acceptability and safety of a 6-week intervention (MYOPAP) which includes oropharyngeal myofunctional therapy, physical activity guidance, and sleep hygiene education…
- Trial name
- MYOPAP (NCT07879859)
- Testing
- MYOPAP Program
- Where
- Kuwait
- Volunteers
- 14 people
- Sponsor
- Kuwait University
Sleep Deprivation
Voice Biomarkers to Predict Excessive Daytime Sleepiness
This study aims at measuring the impact of a night of sleep deprivation over the vocal characteristics of healthy subjects.To do so, the subjects takes a Multiple Sleep Latency Test (MSLT) the day after a night of total sleep…
- Trial name
- SOMVOICE (NCT04942574)
- Testing
- Total sleep deprivation, Normal sleep
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University Hospital, Bordeaux
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.
Prader-Willi Syndrome, Excessive Daytime Sleepiness
Impact of Bright Light Therapy on Prader-Willi Syndrome
This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome
- Conditions
- Prader-Willi Syndrome, Excessive Daytime Sleepiness, Hyperphagia, Body Weight
- Trial name
- PWS-LT (NCT05939453)
- Testing
- Bright Light Therapy
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Maimonides Medical Center
Sleep Disturbance
Bonafide Sleep Supplement for Menopausal Women With Sleep Complaints
This open-label study was designed to evaluate whether a daily dietary sleep supplement could improve sleep quality and related daytime well-being in menopausal women aged 40 to 65 with sleep complaints.
- Trial name
- NCT07839312
- Testing
- S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium Glycinate
- Where
- United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Bonafide Health
COPD
Comparing Fluticasone-salmeterol in Chronic Obstructive Pulmonary Disease (COPD) and Sleep
Fluticasone (Advair), an inhaled corticosteroid and salmeterol, a long-acting beta agonist, are approved for use in the management of COPD.
- Trial name
- NCT00731770
- Testing
- Advair 250, Advair 250 - matched
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Milton S. Hershey Medical Center
Poor Quality Sleep
Project REST: Club Sports
Evidence suggests that student athletes frequently experience sleep problems and are aware of the impact of sleep loss on mental and physical outcomes.
- Trial name
- NCT07103759
- Testing
- Refrain from caffeine techniques, Project REST Platform
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Arizona
Myotonic Dystrophy, Type 1 (DM1), Myotonic Dystrophy
Safety, Tolerability and Pharmacokinetics of ERX-963 in Adults With Myotonic Dystrophy Type 1
Participants in this study will receive two treatments, placebo and ERX-963, on different days in a randomized fashion. The primary purpose of this study is to investigate the safety and tolerability of ERX-963 in participants…
- Trial name
- NCT03959189
- Testing
- ERX-963
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- Expansion Therapeutics, Inc.
Excessive Daytime Sleepiness, Obstructive Sleep Apnea
Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, But Still Complaining of Excessive Daytime Sleepiness
The first objective of this study is to demonstrate the efficacy and safety of pitolisant given at 10, 20, or 40 mg per day versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness…
- Trial name
- HAROSA IV (NCT02978651)
- Testing
- Pitolisant (BF2.649)
- Where
- 2 sites in France
- Sponsor
- Bioprojet
Excessive Daytime Sleepiness, Obstructive Sleep Apnea (OSA)
Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawal
In brief, the proposed study will evaluate a recently proposed naturalistic, driving simulation test to identify and measure sleepiness behind the wheel, one of the most underestimated causes of road accidents.
- Conditions
- Excessive Daytime Sleepiness, Obstructive Sleep Apnea (OSA), CPAP Treatment, Driving Simulator Performance
- Trial name
- DS-MWT2 (NCT06872593)
- Testing
- CPAP-withdrawal, Test Sequence
- Where
- Switzerland
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Stefan Lakämper
Obstructive Sleep Apnoea, Excessive Daytime Sleepiness
Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA)
Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range).
- Trial name
- NCT01620554
- Testing
- BF2.649
- Where
- France
- Volunteers
- 110 people
- Sponsor
- Bioprojet
Parkinson Disease, Mild Cognitive Impairment
Auditory Slow Wave Enhancement in Parkinson Disease and Mild Cognitive Impairment
The study aims to assess the efficacy of auditory slow-wave sleep (SWS) enhancement in PD patients and patients with amnestic MCI.
- Trial name
- PDMCI-TS (NCT04736017)
- Testing
- TSB Axo
- Where
- Switzerland
- Volunteers
- 48 people
- Sponsor
- University of Zurich
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
Abdominal Obesity
Effects of Weight Reduction on Sleep and Alertness in Long-distance Truck and Bus Drivers
The study is a year-long health-behaviour intervention in obese, male truck-drivers to lose weight moderately by 10%, using monthly individual counseling.
- Trial name
- SF-Truck (NCT00893646)
- Testing
- weight loss counseling
- Where
- 3 sites in Finland
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- UKK Institute
Hepatic Encephalopathy
Effect of Rifaximine on Sleep Disorders in Patients Suffering From Hepatic Encephalopathy
Hepatic encephalopathy is responsible for sleep disturbances and daytime sleepiness. The purpose of our study is to assess sleep quality, quantity, sleep schemes and physical activity in patients suffering from HE, before and…
- Trial name
- NCT02163837
- Testing
- rifaximine
- Where
- Belgium
- Volunteers
- 15 people
- Sponsor
- Centre Hospitalier Universitaire Saint Pierre
Narcolepsy With Cataplexy, Excessive Daytime Sleepiness
Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)
Double blind, randomized, parallel groups study of Pitolisant versus placebo, in narcoleptic patients experiencing EDS, and cataplexy (minimum of 3 complete or partial cataplexy attacks per week).
- Trial name
- NCT01800045
- Testing
- Pitolisant
- Where
- Hungary
- Volunteers
- 103 people
- Sponsor
- Bioprojet
Narcolepsy Without Cataplexy, Narcolepsy With Cataplexy
Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy
This EAP will be open to provide access to treatment with pitolisant while a U.S. New Drug Application (NDA) is being prepared and submitted for review for marketing approval.
- Trial name
- NCT03433131
- Testing
- Pitolisant
- Where
- 71 sites in United States
- Sponsor
- Harmony Biosciences Management, Inc.
Parkinson's Disease
Varenicline Treatment for Excessive Daytime Sleepiness in Parkinson's Disease
The effect of varenicline, an alpha4beta2 nicotinic receptor partial agonist on excessive daytime sleepiness in Parkinson's disease will be studied in a randomized, double blind, placebo-controlled clinical trial with a…
- Trial name
- VESPA (NCT02473562)
- Testing
- Varenicline
- Where
- 2 sites in Netherlands
- Volunteers
- 22 people
- Sponsor
- Amsterdam UMC, location VUmc