Clinical trials: Daytime Sleepiness, Excessive
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
Sleep Initiation and Maintenance Disorders, Circadian Rhythm Sleep Disorders
Light Exposure to Treat Sleep Disruption in Older People
The purpose of this study is to test whether shifts in the timing of the biological clock to a later hour (phase delay shifts of the human circadian system) can be produced in response to four successive evenings of light…
- Conditions
- Sleep Initiation and Maintenance Disorders, Circadian Rhythm Sleep Disorders, Hypersomnia
- Trial name
- NCT00427323
- Testing
- light exposure
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Institute on Aging (NIA)
Excessive Daytime Sleepiness
Characterization of Children with Complaints of Excessive Daytime Sleepiness
10% of the population suffers from excessive daytime sleepiness. This can be explained by a variety of etiologies: psychiatric disorders, altered sleep quantity or quality, hypersomnia...
- Trial name
- CEPSDE (NCT06898008)
- Testing
- Assessment of socio-demographic, anthropometric, psychometric and clinical characteristics
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Hospices Civils de Lyon
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
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
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
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
Parkinson Disease
Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease
This is a multi-center, open-label, single-arm 8-week investigation of Selegiline for treatment of EDS in PD patients.
- Trial name
- NCT04870372
- Testing
- Selegiline
- Where
- 4 sites in China
- Volunteers
- 141 people
- Sponsor
- Second Affiliated Hospital of Soochow University
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.
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
Apnea, Sleep Disorders
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
This study is being done to learn about the safety and effects of a study medicine called berobenatide (bear-oh-BEN-uh-tide). The study will see if berobenatide can help adults with breathing problems during sleep (obstructive…
- Conditions
- Apnea, Sleep Disorders, Overweight and/or Obesity
- Trial name
- VESPER-OSA 2 (NCT07881757)
- Testing
- Berobenatide
- Where
- 2 sites in United States
- Volunteers
- 258 people
- Sponsor
- Pfizer
Dystrophia Myotonica 1
Methylphenidate in Myotonic Dystrophy Type 1
The purpose of this study is to determine whether methylphenidate is effective in the treatment of excessive daytime sleepiness due to myotonic dystrophy type 1 (DM1).
- Trial name
- NCT01421992
- Testing
- Methylphenidate
- Where
- Canada
- Volunteers
- 28 people
- Sponsor
- Laval University
Excessive Daytime Sleepiness, Obstructive Sleep Apnea
Pitolisant (BF2.649) in the Treatment of EDS in Patients With OSA
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
- HAROSA3 (NCT02739568)
- Testing
- Pitolisant (BF2.649)
- Where
- 6 sites in Bulgaria, North Macedonia
- Volunteers
- 389 people
- Sponsor
- Bioprojet
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
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
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.
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
Insomnia
Digital Sleep Program for College Students with Insomnia
This randomized controlled trial (RCT) study aims to evaluate the effectiveness of a digital-based multimodal sleep management program compared to a waitlist control group in improving sleep-related outcomes, including insomnia…
- Trial name
- DSP-CS (NCT06853106)
- Testing
- Waitlist control group, digital-based multimodal sleep management program
- Where
- Taiwan
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Taipei Medical University
Parkinson's Disease
Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease
To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime…
- Trial name
- HARPS2 (NCT01066442)
- Testing
- BF2.649 (Pitolisant)
- Where
- Germany
- Volunteers
- 273 people
- Sponsor
- Bioprojet
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