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NCT01102998 · ClinicalTrials.gov registry record
Assessment of Sleep Complaints in Brain Tumor Survivors
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 153
- Enrollment target
NCT01102998: Completed study, sponsored by St. Jude Children's Research Hospital.
NCT01102998 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 153 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01102998 has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 153 participants
- Enrollment target
Study Summary
Survivors of pediatric brain tumors are noted to have increased rates of excessive daytime sleepiness. However, very little data are available regarding the specific sleep disturbances of pediatric brain tumor survivors. Children ages 8 to 18 years of age who are at least 5 years from diagnosis and at least 2 years post treatment or observation only for a brain tumor will be targeted to assess the prevalence of sleep complaints. The study focuses on the following objectives: * To estimate sleep disturbance in a cohort of pediatric brain tumor survivors. * Estimate the rates of parent- and self-reported excessive daytime sleepiness in pediatric brain tumors * Estimate the rates of parent-reported sleep-disordered breathing, including snoring and witnessed apneas, in pediatric brain tumor survivors * Estimate the rates of parent- and self-reported behavioral sleep problems, including nocturnal enuresis, bedtime resistance, nighttime awakenings, nightmares, and fatigue in pediatric brain tumor survivors. The Study focuses on the following secondary objectives: * To describe bedtime patterns and sleep hygiene of pediatric brain tumor survivors. * Estimate the typical parent- and self-reported weekday sleep duration of pediatric brain tumor survivors * Estimate the typical parent- and self-reported weekend sleep duration of pediatric brain tumor survivors and if it differs from the weekday sleep duration * Estimate the typical parent- and self-reported consistency of sleep hygiene in pediatric brain tumor survivors
Primary Outcome
* Estimate the rates of parent- and self-reported excessive daytime sleepiness in pediatric brain tumors * Estimate the rates of parent-reported sleep-disordered breathing, including snoring and witnessed apneas, in pediatric brain tumor survivors * Estimate the rates of parent- and self-reported behavioral sleep problems, including nocturnal enuresis, bedtime resistance, nighttime awakenings, nightmares, and fatigue in pediatric brain tumor survivors.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2010-04 |
| Est. Completion | 2013-04 |
What the finished NCT01102998 record still lists
NCT01102998 is an observational study that tracks outcomes without assigning an intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01102998 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01102998 about?
NCT01102998 is a clinical study titled "Assessment of Sleep Complaints in Brain Tumor Survivors". Survivors of pediatric brain tumors are noted to have increased rates of excessive daytime sleepiness. However, very little data are available regarding the specific sleep disturbances of pediatric brain tumor survivors. Children ages 8 to 18 years of age who are at least 5 years from diagnosis and ...
What is the current status of trial NCT01102998?
This trial is currently completed. The enrollment target is 153 participants. The study started on 2010-04. Estimated completion is 2013-04.
Who is sponsoring clinical trial NCT01102998?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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