Clinical trials: Excessive Daytime Sleepiness
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'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
Narcolepsy Type 1
A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
- Trial name
- NCT07540897
- Testing
- ALKS 2680 Dose 1, ALKS 2680 Dose 2
- Where
- 20 sites in United States, Belgium and 3 more
- Volunteers
- 150 people
- Sponsor
- Alkermes, Inc.
Narcolepsy, Excessive Daytime Sleepiness
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
This study is being conducted to evaluate the safety, tolerability, blood distribution and effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.
- Trial name
- NCT02215499
- Testing
- Sodium Oxybate, JZP-386
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Concert Pharmaceuticals
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, 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
Sleep, Sleep Disorders, Circadian Rhythm
Effects of Delayed School Start Times on Sleep, Mental Health, and Academic Performance Among Norwegian Adolescents
The aim is to investigate whether later school start times have positive effects on high school students' sleep patterns, mental health and daytime functioning.
- Conditions
- Sleep, Sleep Disorders, Circadian Rhythm, Psychiatric Disorder, Sleepiness, Daytime
- Trial name
- NCT06657482
- Testing
- Delayed school start time
- Where
- Norway
- Volunteers
- 583 people, healthy volunteers welcome
- Sponsor
- University of Bergen
Central Nervous System Tumor, Pediatric, Fatigue
Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy
RATIONALE: Methylphenidate hydrochloride or modafinil may help reduce daytime sleepiness and improve the quality of life of patients with excessive daytime sleepiness after cancer therapy.
- Conditions
- Central Nervous System Tumor, Pediatric, Fatigue, Specific Disorders of Sleep
- Trial name
- NCT01348607
- Testing
- methylphenidate hydrochloride, modafinil
- Volunteers
- 1 people
- Sponsor
- University of South Florida
Traumatic Brain Injury, Fatigue
Treatment of Post-Traumatic Brain Injury (Post-TBI) Fatigue With Light Therapy
This study aims to evaluate the efficacy of 4 weeks of daily light exposure in reducing Post-Traumatic Brain Injury (TBI) Fatigue immediately post-treatment and at a one-month follow up.
- Trial name
- NCT01725750
- Testing
- Bright White Light (BWL), Dim Red Light (DRL)
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
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
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.
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
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
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
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
Parkinson Disease
Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)
This clinical trial is designed to evaluate the safety and potential efficacy of Xyrem for the treatment of excessive daytime sleepiness (EDS) and nocturnal sleep disturbance in patients with mild to moderate Parkinson's Disease…
- Trial name
- Xyrem (NCT00641186)
- Testing
- sodium oxybate
- Volunteers
- 30 people
- Sponsor
- Baylor College of Medicine
Narcolepsy
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.
- Trial name
- NCT01485770
- Testing
- ADX-N05
- Where
- 10 sites in United States
- Volunteers
- 33 people
- Sponsor
- Jazz Pharmaceuticals
Obstructive Sleep Apnea, Excessive Daytime Sleepiness
BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP.
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
- HAROSA2 (NCT01072968)
- Testing
- BF2.649
- Where
- France
- Volunteers
- 268 people
- Sponsor
- Bioprojet
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
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