Clinical trials: Disorders of Excessive Somnolence
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
Narcolepsy Type 1, Hypersomnia
A Pilot Observational Study to Assess the Ability of Continuous 'Home' EEG to Accurately Diagnose Narcolepsy and Demonstrate Response to Treatment
The goal of this pilot observational study is to assess the ability of continuous 'home' EEG to accurately diagnose Narcolepsy in children and young people with hypersomnia.
- Trial name
- NCT05983731
- Volunteers
- 60 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Sleep Apnea, Obstructive, Sleep Apnea Syndromes
Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children
Obstructive sleep-disordered breathing (SDB) affects 2-3% of children and may lead to problems with nighttime sleep and daytime behavior, learning, sleepiness, and mood.
- Conditions
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Child Behavior Disorders, Attention Deficit Disorder With Hyperactivity
- Trial name
- NCT01554527
- Testing
- CPAP treatment, No CPAP treatment
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Michigan
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
Pregnancy Related, Narcolepsy
WAKIX® (Pitolisant) Pregnancy Registry
The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant…
- Trial name
- NCT05536011
- Testing
- Pitolisant, Comparator Products
- Where
- United States
- Volunteers
- 1,329 people
- Sponsor
- Harmony Biosciences Management, Inc.
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
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
Narcolepsy
Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription
Patients will be followed up for max 18 months. Information on the Adverse Events and potential misuse or abuse of Xyrem ® will be collected.
- Trial name
- NCT00244465
- Where
- 41 sites in Austria, Belgium and 7 more
- Volunteers
- 750 people
- Sponsor
- UCB Pharma
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.
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
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
Narcolepsy
Study of the Academic and Professional Course of Narcoleptic Patients (NARCOSCOL-NARCOVITAE)
Narcolepsy is a chronic, disabling, and rare sleep disorder (prevalence 1/2500) characterized by excessive daytime sleepiness and, in some patients, falls in muscle tone related to emotions (cataplexies).
- Trial name
- NCT03765892
- Testing
- Questionnaire (Adult), Questionnaire (Children)
- Where
- 18 sites in France
- Volunteers
- 1,605 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Sleep Apnea, Obstructive
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
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 obstructive sleep…
- Trial name
- NCT00107809
- Testing
- Modafinil
- Where
- 64 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
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
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
Narcolepsy, Obstructive Sleep Apnea
Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale
The purpose of this study is to test a pediatric narcolepsy patient reported outcomes tool to assess pediatric narcolepsy symptoms and their effect on daily functioning and quality of life.
- Trial name
- PN-PROS (NCT05373979)
- Where
- United States
- Volunteers
- 212 people
- Sponsor
- Boston Children's Hospital
Narcolepsy
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
This study is to evaluate the pharmacokinetics, pharmacodynamics, and safety of single and multiple doses of armodafinil (50, 100, and 150 mg/day) in children and adolescents with excessive sleepiness associated with narcolepsy.
- Trial name
- NCT01624480
- Testing
- Armodafinil
- Where
- 24 sites in United States, Finland
- Volunteers
- 40 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Hypersomnia, Narcolepsy
Feasibility Study of At-Home EEG Monitoring for Hypersomnia
The central hypothesis is that home EEG monitoring (Dream 3 wearable) can be feasibly utilized for data capture of continuous sleep and wake measurements for the diagnostic evaluation and treatment monitoring of hypersomnia.
- Trial name
- NCT05627388
- Testing
- Dreem 3 System At-Home Monitoring
- Volunteers
- healthy volunteers welcome
- Sponsor
- Kaiser Permanente
Narcolepsy With Cataplexy
A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy
The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics subjects with narcolepsy that includes cataplexy.
- Trial name
- NCT02221869
- Testing
- Xyrem
- Where
- 20 sites in United States, France and 2 more
- Volunteers
- 106 people
- Sponsor
- Jazz Pharmaceuticals
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