Clinical trials: Sleepiness
Narcolepsy
TElemedicine for NARcolepsy
The TENAR trial is the first randomized controlled trial (RCT) designed to evaluate the feasibility, efficacy, safety, and costs of a Telemedicine multidisciplinary approach for the management of narcolepsy.
- Trial name
- TENAR (NCT04316286)
- Testing
- Tele-multidisciplinary care, Standard care
- Where
- Italy
- Volunteers
- 202 people
- Sponsor
- Azienda Usl di Bologna
Sleep Hygiene, Habit, Good Sleep
Sleep Hygiene Training in Gymnasts: Sleep Behaviour, Quality and Sleepiness
Sleep is essential to human health and well-being. Lack of or poor sleep can negatively impact cognitive function, mood, and physical performance.
- Trial name
- NCT06418737
- Testing
- Sleep HygieneTraining
- Where
- Turkey (Türkiye)
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Abant Izzet Baysal University
Narcolepsy
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
Primary Objectives: The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with…
- Trial name
- NCT00107796
- Testing
- Modafinil
- Where
- 73 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
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.
Narcolepsy Type 1
Clinical and Neurophysiological Characteristics of Narcolepsy
The study is the first attempt in post-Soviet Russian history to collect and analyze the existing available data of narcolepsy cohort in order to get prove characteristics of narcolepsy in Russia according to known data.
- Trial name
- NCT05375890
- Testing
- no intervention
- Where
- 11 sites in Russia
- Volunteers
- 89 people
- Sponsor
- I.M. Sechenov First Moscow State Medical University
Sleep, Sleep Inertia
Sensible Sleep: Measuring Alarm and Snooze Behavior in Teens Using Wearables and Smartphones
Pilot data suggests that working professionals and college students routinely use alarms and snooze. Alarm usage and snoozing is associated with several negative health biomarkers including lighter sleep, higher resting heart…
- Conditions
- Sleep, Sleep Inertia, Stress
- Trial name
- NCT04786678
- Testing
- Cell phone notification
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Notre Dame
Wakefulness Disorder, Narcolepsy
Hypersomnia in the Paediatric Population
This is a 36-month, multicentric, cross-sectional study involving a paediatric population aged 6 to 17 years. Three groups will be included: Group A: children from the general population with no complaints of sleepiness; Group B…
- Conditions
- Wakefulness Disorder, Narcolepsy, Idiopathic Hypersomnia
- Trial name
- SOMNO-PED (NCT07766343)
- Testing
- Sleepness and wakeness scale, Polysomnography, Actimetry
- Where
- France
- Volunteers
- 760 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Fatigue, Sleep Deprivation
Effect and Utilization of Protected Time Among Interns on Extended Duty-Hour Call Shifts
This study will test the feasibility and effectiveness of protected time for physicians in training during 30 hour shifts in a medical intensive care unit. The primary outcome will be fatigue.
- Conditions
- Fatigue, Sleep Deprivation, Depression
- Trial name
- NCT00983008
- Testing
- Protected time and Dedicated time
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Providence Health & Services
Narcolepsy Type 1, Narcolepsy Type 2
Improving Social Relationships for Adolescents With Central Disorders of Hypersomnolence
The goal of this study is to test a web-based psychoeducational resource for adolescents with central disorders of hypersomnolence and their families.
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- NCT06251063
- Testing
- Web-based psychoeducational resource
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Boston Children's Hospital
Sleep Deprivation, Sleep
Effects of Napping in Sleep-Restricted Adolescents
To examine the neurobehavioural responses to two successive cycles of sleep restriction and recovery in adolescents, and to determine the benefits of napping on cognitive performance, alertness, and mood.
- Trial name
- NCT02838095
- Testing
- Nap
- Where
- Singapore
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Duke-NUS Graduate Medical School
Hypersomnia
A Multi-Signal Based Monitoring System for CNS Hypersomnias
This is a retrospective and prospective cohort study. There are 600 subjects (age 9-45) will be collected.The purposes of this study are as follows:(1) The main purpose is to use Multi-Signal Based Monitoring System to link with…
- Trial name
- NCT05443373
- Where
- 2 sites in Taiwan
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Chang Gung Memorial Hospital
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, Idiopathic Hypersomnia
Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence
In humans, selective loss of orexin neurons is responsible for type 1 narcolepsy (NT1), or narcolepsy with cataplexy, or orexin deficiency syndrome.
- Conditions
- Narcolepsy, Idiopathic Hypersomnia, Cataplexy
- Trial name
- MRM-OREX (NCT05615584)
- Testing
- Quantitative mass spectrometry assay
- Where
- France
- Volunteers
- 117 people
- Sponsor
- University Hospital, Montpellier
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
Parkinson's Disease
Study for Rasagiline Effect on Sleep Trial(REST)in Parkinson's Disease
The main objective of this study is to evaluate the effect of Azilect® on sleep disturbances in Parkinson's Disease patients, after 2 months of treatment.
- Trial name
- PD (NCT01032486)
- Testing
- Rasagiline mesylate
- Volunteers
- 120 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
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
Narcolepsy, REM Sleep Behavior Disorder
Investigation of Clinical Feature and Brain Function in Narcoleptic Patients
This study evaluates the PSG and cerebral metabolism and functions in narcolepsy with/without RBD
- Trial name
- NCT03376568
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Tang-Du Hospital
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.
Narcolepsy
Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or obstructive sleep apnea/hypopnea…
- Trial name
- NCT00214968
- Testing
- Modafinil
- Volunteers
- 92 people
- Sponsor
- Cephalon
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