Clinical trials: Sleep Disorders in Children
Restless Legs Syndrome
Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome
This was a multicenter, open-label, dose-escalation, Phase 2A study with multiple administrations of the rotigotine transdermal system.
- Trial name
- NCT01495793
- Testing
- Rotigotine
- Where
- 12 sites in United States
- Volunteers
- 42 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Sleep Apnea, Sleep Apnea Syndromes in Children
Assessing the Performance of Wesper Lab for Sleep Apnea Diagnosis in Pediatric Populations
The goal of this single arm study is to evaluate the effectiveness of Wesper Lab, previously known as TatchSleep Pro, a wireless home sleep test, as a tool to aid in sleep apnea diagnosis as compared to an overnight…
- Conditions
- Sleep Apnea, Sleep Apnea Syndromes in Children, Sleep Apnea Syndromes
- Trial name
- NCT06218186
- Testing
- Medical Device: Wesper Lab Home Sleep Test
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Wesper Inc
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
Nervousness, Sleep Disorders
PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases
The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.
- Trial name
- 174 (NCT01125605)
- Where
- Germany
- Volunteers
- 325 people
- Sponsor
- Pascoe Pharmazeutische Praeparate GmbH
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, Obstructive
Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children
The feasibility and the validity of the ApneaLink Air home sleep testing (HST) device will be tested in adolescent children. The ApneaLink Air HST device is cleared for the diagnosis of obstructive sleep apnea (OSA) in adults..
- Trial name
- NCT03748771
- Testing
- ApneaLink Air
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- ResMed
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.
Insomnia, Attention Deficit Hyperactivity Disorder
Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia
A multicenter study to evaluate the safety of eszopiclone in children (6 11 years of age, inclusive) and adolescents (12 17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.
- Trial name
- NCT00857220
- Testing
- eszopiclone
- Where
- 89 sites in United States
- Volunteers
- 304 people
- Sponsor
- Sumitomo Pharma America, Inc.
Sleep Problems
Assessment of the Pharmacokinetics of Circadin® in Children With Neurodevelopmental Disorders and Sleep Disturbances
There is increasing evidence that chronic sleep disorders in children with autism spectrum disorder (ASD), Angelman Syndrome (AS) and Smith-Magenis syndrome (SMS) are associated with disturbed melatonin secretion and melatonin…
- Trial name
- NCT01903681
- Testing
- Circadin 2 mg, Circadin 10 mg
- Where
- Netherlands
- Volunteers
- 16 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
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
Insomnia, Attention Deficit Hyperactivity Disorder
Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia
A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention…
- Trial name
- NCT00856973
- Testing
- eszopiclone
- Where
- 73 sites in United States
- Volunteers
- 486 people
- Sponsor
- Sumitomo Pharma America, Inc.
Insomnia
Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults
The purpose of this study is to determine the pharmacokinetic profile, safety, and tolerability of ramelteon in adolescents with insomnia, children with Attention Deficit Hyperactivity Disorder (ADHD) associated with insomnia and…
- Trial name
- NCT00914862
- Testing
- Ramelteon
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Takeda
Inflammatory Bowel Diseases, Depressive Episode
Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health
This study is a large population-based analysis in the United Kingdom (UK) using routine primary care data to investigate the impacts on quality-of-life outcomes and use of healthcare services in people aged 5 - 25 years…
- Conditions
- Inflammatory Bowel Diseases, Depressive Episode, Recurrent Depressive Disorder, Anxiety Disorder
- Trial name
- NCT05206734
- Testing
- No specific intervention
- Where
- United Kingdom
- Volunteers
- 19,469 people, healthy volunteers welcome
- Sponsor
- Momentum Data
Attention Deficit Hyperactivity Disorder
Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
There has been an increased interest in the association between ADHD and sleep disorders over the past years. A high incidence of sleep disturbance, ranging from 10% to 70%, has been identified in ADHD children regardless of…
- Trial name
- Zolkids (NCT00318448)
- Testing
- Zolpidem (SL800750)
- Where
- 2 sites in United States, Canada
- Volunteers
- 201 people
- Sponsor
- Sanofi
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.
Sleep Initiation and Maintenance Disorders
Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia
Given the potential age-related differences in safety, tolerability, pharmacokinetics, and differences in sleep architecture in young children versus adolescent versus adult, studies to identify the appropriate drug and dosage…
- Trial name
- PKiDs (NCT00913614)
- Testing
- Eplivanserin (SR46349)
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Sanofi
Adolescent Behavior, Sleep Disturbance
Personalized Approach To Habits - Sleep
Two arm study, intervention and control, to explore the impact of an app to help high risk teens with asthma improve their sleep
- Conditions
- Adolescent Behavior, Sleep Disturbance, Asthma in Children, Knowledge, Attitudes, Practice
- Trial name
- PATH-S (NCT07029919)
- Testing
- PATH-S app
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- KDH Research & Communication
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.
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
Blood Oxygen Desaturations, Sleep-Disordered Breathing
Assessment of the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for Continuous Vital Parameters Monitoring in Infants and Young Children
During a polysomnography test (PSG) previously prescribed by a physician, the patient also wears the Gaby Baby Band (GBB) during an entire night of sleep.
- Trial name
- WAGSC1 (NCT04886583)
- Testing
- Gabi Baby Band
- Where
- 3 sites in Belgium
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Gabi SmartCare