Clinical trials: Disorders of Excessive Somnolence
Narcolepsy
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy.
- Trial name
- SUVN-G3031 (NCT04072380)
- Testing
- SUVN-G3031
- Where
- 41 sites in United States, Canada
- Volunteers
- 190 people
- Sponsor
- Suven Life Sciences Limited
Narcolepsy Type 1 (NT 1)
Extended-release Sodium Oxybate in Children
The main objectives of this study are to determine the treatment preferences of children with narcolepsy type 1 between Extended-release sodium oxybate and Non-extended-release oxybates (Sodium oxybate or a medication with the…
- Trial name
- NCT06809803
- Testing
- Extended-release sodium oxybate, Non-extended-release oxybates
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Stanford University
Multiple Sclerosis, Multiple Sclerosis Fatigue
Solriamfetol for the Treatment of Multiple Sclerosis Fatigue
Fatigue is a prevalent and disabling symptom in Multiple Sclerosis (MS), affecting up to 90% of patients. Current treatments, including off-label prescriptions of wake-promoting agents, have shown limited effectiveness.
- Trial name
- SOLARIMS (NCT06170970)
- Testing
- Solriamfetol
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Johns Hopkins University
EDS, Cataplexy
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
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 treating excessive daytime sleepiness (EDS), cataplexy…
- Conditions
- EDS, Cataplexy, Fatigue, Narcolepsy
- Trial name
- NCT07675135
- Testing
- HBS-301
- Where
- 53 sites in United States, Canada
- Volunteers
- 258 people
- Sponsor
- Harmony Biosciences Management, Inc.
Idiopathic Hypersomnia
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in participants with idiopathic hypersomnia (IH) age ≥18 years.
- Trial name
- NCT05156047
- Testing
- Open-label Pitolisant, Double-blind Pitolisant
- Where
- 58 sites in United States
- Volunteers
- 214 people
- Sponsor
- Harmony Biosciences Management, Inc.
Narcolepsy
Evaluation of Academic and Professional Trajectories of Narcoleptic Patients
Narcolepsy is a chronic, disabling condition characterized by excessive daytime sleepiness and, in some patients, falls in muscle tone related to emotions (cataplexies). It often begins in childhood or in young adults.
- Trial name
- NARCOWORK (NCT03173378)
- Testing
- Questionnaires
- Where
- France
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
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
Sleep Inertia, Caffeine
Delayed-release Bedtime Caffeine and Sleep Inertia Symptoms Immediately Upon Awakening
Sleep inertia (sometimes also referred to as sleep drunkenness) is a disabling state of increased sleepiness, impaired mood and reduced vigilance immediately upon awakening.
- Conditions
- Sleep Inertia, Caffeine, Placebo
- Trial name
- NCT04975360
- Testing
- Caffeine
- Where
- Switzerland
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Zurich
Healthy Participants, Narcolepsy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy participants.
- Trial name
- NCT03748979
- Testing
- TAK-925
- Where
- 3 sites in Japan
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Takeda
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
Idiopathic Hypersomnia
Study of SDX in Patients With Idiopathic Hypersomnia (IH)
This is a study of the safety, efficacy and pharmacokinetics (PK) of Serdexmethylphenidate (SDX) compared to placebo in subjects with Idiopathic Hypersomnia (IH).
- Trial name
- NCT05668754
- Testing
- Serdexmethylphenidate
- Where
- 41 sites in United States
- Volunteers
- 66 people
- Sponsor
- Zevra Therapeutics
Excessive Daytime Somnolence, Sleep Deprivation
Start Times and Restful Sleep
The purpose of this study is to evaluate the efficacy of later school start times in increasing student sleep, and examine the association between later start times and physical activity, screen time, and commute time.
- Trial name
- STaRtS (NCT04049682)
- Testing
- Delayed School Start Time
- Where
- 2 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of California, San Diego
Hypersomnia, Sleepiness, Excessive Daytime
Analysis of New Salivary Biomarkers to Evaluate Excessive Diurnal Sleepiness in Children With Hypersomnia
Excessive diurnal sleepiness is characterized by an incapacity to stay awake, in favour of sleep occurrence. This sleepiness might be secondary to a sleep disorder; when it is not the case, it is primary hypersomnia (including…
- Trial name
- BIOSOM (NCT05183464)
- Testing
- saliva samples, Stanford sleepiness scale, Karolinska Sleepiness Scale
- Where
- France
- Volunteers
- 116 people
- Sponsor
- Hospices Civils de Lyon
Obstructive Sleep Apnea
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
- Trial name
- OSA (NCT02348606)
- Testing
- JZP-110
- Where
- 59 sites in United States, Canada and 3 more
- Volunteers
- 476 people
- Sponsor
- Jazz Pharmaceuticals
Parkinson's Disease, Excessive Daytime Somnolence
Caffeine for Excessive Daytime Somnolence in Parkinson's Disease
Many patients with Parkinson's disease (PD) have sleep problems, including excessive sleepiness during the day. This is probably due to degeneration of sleep-regulating areas in the brain.
- Trial name
- NCT00459420
- Testing
- Caffeine 100-200 mg BID
- Where
- 2 sites in Canada
- Volunteers
- 58 people
- Sponsor
- Ron Postuma
Obstructive Sleep Apnea
Delphi Consensus Excessive Daytime Sleepiness in OSA
The objective of this study is to generate expert consensus statements on the differential diagnosis, definition, and management of EDS in patients with OSA who are adequately treated with primary therapy.
- Trial name
- NCT05055271
- Where
- United Kingdom
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- King's College London
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
Narcolepsy
Study of the Academic and Professional Course of Narcoleptic Patients (NARCOSCOL-NARCOVITAE)
Narcolepsy is a chronic, disabling, and rare sleep disorder (prevalence 1/2500) characterized by excessive daytime sleepiness and, in some patients, falls in muscle tone related to emotions (cataplexies).
- Trial name
- NCT03765892
- Testing
- Questionnaire (Adult), Questionnaire (Children)
- Where
- 18 sites in France
- Volunteers
- 1,605 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
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
Shift-Work Sleep Disorder, Insomnia
Fire Fighter Fatigue Management Program: Operation Fight Fatigue
Firefighters frequently work extended duration shifts and long work weeks which have adverse effects on alertness, health, safety and performance.
- Conditions
- Shift-Work Sleep Disorder, Insomnia, Restless Leg Syndrome, Obstructive Sleep Apnea
- Trial name
- NCT01672502
- Testing
- Sleep health education provided via a web-based program, Sleep disorder detection and treatment, Optimization of Sleep in Fire Station
- Where
- United States
- Volunteers
- 620 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital