Clinical trials: Excessive Daytime Somnolence
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
Excessive Daytime Sleepiness, Parkinson's Disease
Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients
The objective of this trial is to define the minimum effective dose of BF 2.649 between 5 mg, 10 mg, 20 mg or 40 mg versus placebo in reducing the Excessive Daytime Sleepiness of Parkinson's disease patients
- Trial name
- NCT00642928
- Testing
- BF 2.649 5 mg, BF 2.649 10 mg, BF 2.649 20 mg
- Where
- France
- Volunteers
- 108 people
- Sponsor
- Bioprojet
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.
Acid Reflux Disease, Obstructive Sleep Apnea
Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea
The purpose of this study is to determine if using Pantoprazole decreases your daytime sleepiness and improves your reaction time when compared to using a placebo (sugar pill).
- Trial name
- NCT00307944
- Testing
- Pantoprazole
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- University of Cincinnati
Prader-Willi Syndrome
A Study of Pitolisant in Patients With Prader-Willi Syndrome
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.
- Trial name
- NCT06366464
- Testing
- Pitolisant tablet
- Where
- 57 sites in United States, Australia and 11 more
- Volunteers
- 134 people
- Sponsor
- Harmony Biosciences Management, Inc.
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.
Sleep, Circadian Rhythm
Morning Bright Light Therapy and Daytime Functioning in University Students
This study tests whether a week of morning bright light therapy changes how well healthy young adults sleep and how alert, positive, and mentally sharp they feel during the day.
- Conditions
- Sleep, Circadian Rhythm, Daytime Sleepiness, Mood
- Trial name
- BLIGHT (NCT07685262)
- Testing
- Bright light therapy (10,000 lux light box)
- Where
- Hong Kong
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- The Hong Kong Polytechnic University
Narcolepsy, Cataplexy Narcolepsy
Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy.
- Conditions
- Narcolepsy, Cataplexy Narcolepsy, Excessive Sleepiness
- Trial name
- CONCERT (NCT03881852)
- Testing
- AXS-12 (Reboxetine)
- Where
- 14 sites in United States
- Volunteers
- 21 people
- Sponsor
- Axsome Therapeutics, Inc.
Obstructive Sleep Apnea, Excessive Daytime Sleepiness
BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS
Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose.
- Trial name
- HAROSA1 (NCT01071876)
- Testing
- BF2.649
- Where
- France
- Volunteers
- 244 people
- Sponsor
- Bioprojet
Insomnia, Blindness
Melatonin for Circadian Sleep Disorders in the Blind
This research project consists of a three part study with five embedded sub studies. The first study phase identifies "body rhythms" of sleepiness/wakefulness and of melatonin levels for each subject (including sub-study 1).
- Conditions
- Insomnia, Blindness, Daytime Sleepiness
- Trial name
- NCT00911053
- Testing
- Melatonin, Regular Sleep Schedule, Light
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Oregon Health and Science University
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.
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
Parkinson's Disease
Circadian Rhythms and Sleep-Wake Cycles 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
- NCT01742182
- Testing
- Light exposure
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Major Depressive Disorder (MDD)
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
The purpose of this study is to assess the efficacy, safety and tolerability of ALKS 7290 following oral administration in adult participants with Major Depressive Disorder.
- Trial name
- NCT07901179
- Testing
- ALKS 7290 Dose
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Alkermes, 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
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.
Narcolepsy
Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV)
This is a multicentric international phase III, double blind randomized study assessing efficacy and safety in parallel group of BF2.649 (pitolisant) compared to placebo in add-on to sodium oxybate of narcoleptic patients with…
- Trial name
- HARMONY IV (NCT01789398)
- Testing
- BF2.649
- Where
- France
- Volunteers
- 51 people
- Sponsor
- Bioprojet
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, Excessive Daytime Sleepiness
Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2…
- Conditions
- Narcolepsy, Excessive Daytime Sleepiness, Cataplexy Narcolepsy
- Trial name
- NCT04923594
- Testing
- mazindol extended release
- Where
- 22 sites in United States
- Volunteers
- 67 people
- Sponsor
- NLS Pharmaceutics