Clinical trials: Daytime Sleepiness, Excessive
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
Sleepiness, Daytime
Effects of Litebook EDGE™ Phototherapy on Academic Performance and Brain Activity
As children pass through puberty the timing of their sleep-wake cycle shifts and they experience a strong urge to stay up and awaken late.
- Trial name
- LiteBook (NCT05383690)
- Testing
- LED bright light treatment device
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Mclean Hospital
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
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
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.
Parkinson's Disease, Sleep Disorder; Excessive Somnolence
Light Therapy Treatment in Parkinson's Disease Patients With Daytime Somnolence
Study objectives are to determine the efficacy, safety and tolerability of bright light treatment in Parkinson's Disease (PD) patients with daytime sleepiness.
- Trial name
- NCT01338649
- Testing
- Bright Light Treatment (Sun Ray Sunbox SB-558), Dim red light (Sun Ray Sunbox SB-558)
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Northwestern University
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
Prader-Willi Syndrome, Excessive Daytime Sleepiness
Impact of Bright Light Therapy on Prader-Willi Syndrome
This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome
- Conditions
- Prader-Willi Syndrome, Excessive Daytime Sleepiness, Hyperphagia, Body Weight
- Trial name
- PWS-LT (NCT05939453)
- Testing
- Bright Light Therapy
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Maimonides Medical Center
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
Sleep Apnea, Obstructive
OSA (oRisk of Obstructive Sleep Apnea and Traffic Accidents Among Bus Drivers in Ecuador: is There a Significant Association
Our study aims to determine the frequency of individuals at high risk of obstructive sleep apnea, and excessive daytime sleepiness, as well as any potential association between these conditions and traffic accidents among a…
- Trial name
- NCT05175287
- Where
- Ecuador
- Volunteers
- 340 people
- Sponsor
- Respiralab
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
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.
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
Sleep Deprivation, Athletic Performance
Strategic Daytime Napping Enhances Agility and Lowers Perceived Exertion But Does Not Improve Fatigue Resistance in Adolescent Soccer Players
Background Daytime napping is increasingly incorporated into athletic recovery routines to manage sleepiness and support alertness.
- Conditions
- Sleep Deprivation, Athletic Performance, Fatigue
- Trial name
- NCT07314645
- Testing
- Pro Agility Test, Repeated-Sprint Ability (RSA) Test, Rate of Perceived Exertion (RPE)
- Where
- Turkey (Türkiye)
- Volunteers
- 16 people
- Sponsor
- Uludag University
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
Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients
The initial portion of the protocol involves discontinuing any medications for cataplexy that the patient may be taking. Subsequently, the patient is prescribed a dose of oral solution of study drug or placebo over a 10-11 week…
- Trial name
- NCT00049803
- Testing
- sodium oxybate
- Where
- 45 sites in United States, Canada and 1 more
- Volunteers
- 200 people
- Sponsor
- Orphan Medical
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
Excessive Daytime Sleepiness, Cataplexy
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
- Conditions
- Excessive Daytime Sleepiness, Cataplexy, Narcolepsy
- Trial name
- NCT02720744
- Testing
- FT218
- Where
- 57 sites in United States, Australia and 4 more
- Volunteers
- 212 people
- Sponsor
- Avadel
Hypersomnia in Children
Amylase and Hypersomnia
Hypersomnia is defined as a reduced ability to remain awake during the day. There are basically two types of central hypersomnia: narcolepsy and idiopathic hypersomnia.
- Trial name
- Amylase (NCT01926405)
- Testing
- saliva collection
- Where
- France
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon