Clinical trials: Disorders of Excessive Somnolence
Disorders of Excessive Somnolence
Test-retest Reliability of the Maintenance of Wakefulness Test in Participants With Hypersomnolence
This study will provide the first measurement of the test-retest reliability of the Maintenance of Wakefulness Test (MWT) with a prospective multicenter design.
- Trial name
- REWIND (NCT07120061)
- Testing
- First MWT, second MWT, actimetry
- Where
- 4 sites in France
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University Hospital, Bordeaux
Mental Health Issue, Insomnia
Promoting Teenage Sleep for Improved Mental Health and School Performance
The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent sleep and prevent future depressive symptoms.
- Conditions
- Mental Health Issue, Insomnia, Depression, Anxiety
- Trial name
- TeenSleep (NCT06306092)
- Testing
- Sleep on Schedule, Technology restriction
- Where
- Sweden
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Kristianstad University
Narcolepsy Type 2
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2
The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.
- Trial name
- Vibrance-2 (NCT06555783)
- Testing
- ALKS 2680
- Where
- 47 sites in United States, Australia and 6 more
- Volunteers
- 93 people
- Sponsor
- Alkermes, Inc.
Shift-Work Related Sleep Disturbance
Lemborexant Shift Work Treatment Study
Insomnia and daytime sleepiness are common complaints among night shift workers, but effective sleep treatments in shift workers are lacking.
- Trial name
- NCT05344443
- Testing
- Lemborexant
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- University of California, San Francisco
Excessive Daytime Sleepiness, Obstructive Sleep Apnea
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
The purpose of study JZP110-405 is to determine whether solriamfetol is effective at improving cognitive function in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) plus impaired…
- Conditions
- Excessive Daytime Sleepiness, Obstructive Sleep Apnea, Impaired Cognitive Function
- Trial name
- SHARP (NCT04789174)
- Testing
- Solriamfetol
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 59 people
- Sponsor
- Axsome Therapeutics, Inc.
Long COVID, Long COVID-19
RECOVER-SLEEP: Platform Protocol
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, Sleep Disturbance
- Trial name
- NCT06404086
- Testing
- Modafinil, Solriamfetol, Melatonin
- Where
- 47 sites in United States
- Volunteers
- 830 people
- Sponsor
- Duke University
Excessive Daytime Sleepiness
A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age
Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.
- Trial name
- NCT07082829
- Testing
- ORX142 Tablets
- Where
- 3 sites in United States
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Obstructive Sleep Apnoea (OSA)
A Study Assessing Adult Patients Referred to an NHS Sleep Service With Suspected Obstructive Sleep Apnoea. This Study Aims to Compare the Sunrise Wearable Diagnostic Device Performance and Potential Inclusion in a NHS Diagnostic Pathway With Oximetry and WatchPAT Which Are Currently Used.
The goal of this clinical trial is to evaluate whether the Sunrise device (that measure small jaw movements) can improve the diagnosis and management of Obstructive Sleep Apnoea (OSA) in adults (≥ 18 years) referred to a Sleep…
- Trial name
- SOSA (NCT07269483)
- Testing
- WatchPAT 300, Oximetry, Sunrise
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- Virginia Hawkins
Idiopathic Hypersomnia, Excessive Daytime Sleepiness
A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia
The primary objective of this study is to assess the long-term safety and effectiveness of pitolisant in patients with idiopathic hypersomnia (IH) who completed the Double-Blind Randomized Withdrawal Phase of study HBS-101-CL-010.
- Trial name
- NCT05458128
- Testing
- Pitolisant
- Where
- 32 sites in United States
- Volunteers
- 119 people
- Sponsor
- Harmony Biosciences Management, Inc.
Narcolepsy, Cataplexy
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)
This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- Trial name
- NCT05113745
- Testing
- AXS-12 (reboxetine)
- Where
- 25 sites in United States, Canada
- Volunteers
- 68 people
- Sponsor
- Axsome Therapeutics, Inc.
Parkinson's Disease
Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease
Disruption of sleep and alertness is one of the most disabling non-motor symptoms of Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not well understood, and treatment options remain…
- Trial name
- NCT02909192
- Testing
- Light Therapy Device
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Massachusetts General Hospital
Sleep Apnea, Insomnia
Adult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities.
Rural communities in the southern U.S. suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease, with traditional risk factors explaining only a modest proportion of the excess burden of disease.
- Conditions
- Sleep Apnea, Insomnia, Sleep Deprivation, Sleep Disorders, Circadian Rhythm
- Trial name
- NCT06336525
- Where
- United States
- Volunteers
- 3,680 people
- Sponsor
- Brigham and Women's Hospital
Narcolepsy, Cataplexy
An Open Label Study of FT218 in Subjects With Narcolepsy
An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium…
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Somnolence, Sleep Disorder
- Trial name
- RESTORE (NCT04451668)
- Testing
- FT218
- Where
- 29 sites in United States, Canada
- Volunteers
- 184 people
- Sponsor
- Avadel
Snoring, Mouth Breathing
Does myTAP Oral Appliance Therapy Including a Mouth Shield Lessen Periodontitis in Mouth-Breathers Who Snore?
Mouth breathing, snoring and poor sleep can contribute to and worsen periodontitis (gum disease). The purpose of this study is to test whether the myTAP oral appliance with a mouth shield (OA+) can lessen periodontal symptoms in…
- Conditions
- Snoring, Mouth Breathing, Daytime Sleepiness, Periodontitis
- Trial name
- OAplusPerio (NCT06797089)
- Testing
- Oral appliance therapy plus scaling and root planing on left or right of mouth
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Texas A&M University
Excessive Sleepiness, Shift-work Disorder
Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder
In this research study the investigators want to learn more about whether the medication Solriamfetol improves daytime sleepiness in workers who start work at very early times (between 3 and 6am).
- Trial name
- NCT04788953
- Testing
- Solriamfetol Oral Tablet
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Charles A. Czeisler, PhD, MD
D012893, Sleep Disorder
Prevalence of Sleep Disturbances in Elderly People Hospitalized in Medicine, Psychiatry and Rehabilitation Departments: TOPASE Prospective Study, RIPH 3
Objectives and evaluation criteria: The main objective of this study is to evaluate changes in sleep quality in patients aged 60 and over since their admission to a medical, psychiatric or medical and rehabilitation ward in one…
- Trial name
- TOPASE (NCT06659575)
- Where
- 10 sites in France
- Volunteers
- 104 people
- Sponsor
- University Hospital, Angers
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
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
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
Sleep, Sleep Quality
Nextsense Brain-sensing Buds Study
The purpose of this clinical trial is to explore how the presentation of sleep data impacts sleep quality, sleep-related behaviors (such as sleepiness), and sleep-related anxiety and stress.
- Conditions
- Sleep, Sleep Quality, Sleepiness, Daytime, Technology
- Trial name
- NCT06602960
- Testing
- Accurate Sleep Data Feedback, Inflated Sleep Data Feedback, Deflated Sleep Data Feedback
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- NextSense, Inc.