Clinical trials: Sleep Disturbance
- Condition Sleep Disturbance
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Sleep Disorders
Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities
The purpose of this study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is planned to evaluate the efficacy…
- Trial name
- NCT01906866
- Testing
- Circadin 2/5/10 mg
- Where
- 28 sites in United States, Finland and 3 more
- Volunteers
- 125 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Snoring, Apnea, Obstructive
Dental Appliance to Treat SDB in Children
The clinical hypothesis of this study is that a currently marketed mouthguard may also be able to reduce the symptoms of sleep-disordered breathing in children.
- Conditions
- Snoring, Apnea, Obstructive, Upper Airway Resistance Syndrome, Sleep-Disordered Breathing
- Trial name
- NCT05661747
- Testing
- Vivos Grow/Vivos Way Device
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Vivos BioTechnologies, 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
Transient Insomnia
A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
The purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a potential over-the-counter population with reports of occasional sleeplessness
- Trial name
- NCT00666575
- Testing
- Gabapentin
- Where
- 23 sites in United States
- Volunteers
- 2,105 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Insomnia
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
- Trial name
- NCT06498128
- Testing
- Daridorexant, Non-orexin receptor antagonist medications for insomnia, No insomnia medication
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Sleep Disordered Breathing, Obstructive Sleep Apnea
Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients
The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.
- Conditions
- Sleep Disordered Breathing, Obstructive Sleep Apnea, Central Sleep Apnea
- Trial name
- NCT00922168
- Where
- 2 sites in United States
- Volunteers
- 146 people
- Sponsor
- Cleveland Medical Devices Inc
Insomnia
Zolpidem Postmarketing Study in Adolescent Patients With Insomnia
To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial
- Trial name
- NCT00432198
- Testing
- Zolpidem (Myslee®)
- Where
- 7 sites in Japan
- Volunteers
- 122 people
- Sponsor
- Astellas Pharma Inc
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
Sleep Disorders, Autism Spectrum Disorder
Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders
The purpose of this study is to verify the efficacy of NPC-15 (melatonin 1 mg/d or 4 mg/d) versus placebo to sleep latency with electronic sleep diaries.
- Trial name
- NPC-15-5 (NCT02757066)
- Testing
- NPC-15 Granules Lower Dose, NPC-15 Granules Higher Dose
- Volunteers
- 196 people
- Sponsor
- Nobelpharma
Narcolepsy
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy
The purpose of this study is to investigate the efficacy and safety after administration of TS-091 compared with placebo in patients with narcolepsy.
- Trial name
- NCT03267303
- Testing
- TS-091 5mg, TS-091 10mg
- Where
- 2 sites in Japan, South Korea
- Volunteers
- 53 people
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
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
Insomnia Type; Sleep Disorder
Sleep and Cardiovascular Health in Adolescence
Insomnia is a prevalent and under-recognized disorder in adolescence, particularly in girls, with long-term repercussions for mental and physical health.
- Trial name
- NCT03727906
- Testing
- No pre-sleep arousal manipulation, pre-sleep arousal down-regulation, pre-sleep arousal up-regulation
- Where
- United States
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- SRI International
Sleep Disturbances in Smith-Magenis Syndrome
Development of Clinical Database of Individuals With Smith-Magenis Syndrome and Sleep Disturbances
This database will be used to better understand the sleep problems of people with SMS. This clinical database will be a part of a larger Smith-Magenis Patient Registry used to create an awareness campaign around SMS and the sleep…
- Trial name
- NCT03154697
- Testing
- Data collection of sleep disturbances in individuals with SMS
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Vanda Pharmaceuticals
Cardiac Diseases, Muscular Weakness
Biomarker for Pompe Disease (BioPompe)
Development of a new MS-based biomarker for the early and sensitive diagnosis of Pompe disease from blood (plasma)
- Conditions
- Cardiac Diseases, Muscular Weakness, Hepato-splenomegaly, Lung Disease
- Trial name
- BioPompe (NCT01457443)
- Where
- 4 sites in Germany, India and 1 more
- Sponsor
- CENTOGENE GmbH Rostock
Narcolepsy
Child and Adolescent Registry for Participants With Narcolepsy
CATNAP is a patient registry designed to improve the understanding of the natural history of narcolepsy in pediatric patients. Descriptive statistics on disease characteristics will be performed.
- Trial name
- NCT04899947
- Where
- 25 sites in United States
- Volunteers
- 500 people
- Sponsor
- Jazz Pharmaceuticals
Restless Legs Syndrome
Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome
This is a Phase 2, multicenter, open-label, single-arm, optimal dose, long-term follow-up study of monotherapy administration of rotigotine transdermal patch in adolescents with Restless Legs Syndrome (RLS).
- Trial name
- NCT01498120
- Testing
- Rotigotine
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Autism Spectrum Disorder, Sleep Disorder
Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances
This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.
- Conditions
- Autism Spectrum Disorder, Sleep Disorder, Neurological Disorder, Sleep Disturbance
- Trial name
- NCT05361707
- Testing
- Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Vanda Pharmaceuticals
Restless Legs Syndrome
Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome
The survey is conducted to investigate the safety and efficacy of long-term use of BI-Sifrol Tablets in Restless Legs Syndrome (RLS) patients with or without renal dysfunction in routine medical practice.
- Trial name
- NCT01174459
- Where
- 159 sites in Japan
- Volunteers
- 571 people
- Sponsor
- Boehringer Ingelheim
Narcolepsy, Sleep Apnea, Obstructive
PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
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 OSAHS (obstructive sleep…
- Trial name
- NCT00107848
- Testing
- Modafinil
- Where
- 61 sites in United States, Canada
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Cephalon
Sleep Apnea
Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.
- Trial name
- NCT04031950
- Testing
- Novel wearable paediatric device
- Where
- 2 sites in United Kingdom
- Volunteers
- 200 people
- Sponsor
- Acurable Ltd.