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 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain Tumors Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St . Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

This non-therapeutic single arm study will characterize the prevalence and types of sleep complaints of pediatric brain tumor survivors. Brain tumor survivors ages 8 to 18 years who are at least 5 years post diagnosis and 2 years post active therapy and their parents/guardians will be approached to participate during clinic visits. If the patient and guardian agree to participate, they will be administered three questionnaires in the clinic during the patient's visit. From the medical record, the following variables will be utilized to characterize the subjects and estimate which groups are at greatest risk of sleep disturbances:

Specific brain tumor diagnosis
Location of tumor (cerebral hemispheres, parasellar region, posterior fossa, or spine)
Age at diagnosis
Obesity status
Treatment modality (surgery, radiation therapy, and/or chemotherapy vs. observation only)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥8 to ≤ 18 years of age
Brain tumor survivor
≥5 years post diagnosis
≥2 years post active cancer-directed therapy or observation only
Parents speak and read English fluently
Potential participant reads English fluently
Potential participant/guardian willing to sign consent

Exclusion criteria

Survivor of any cancer other than a brain tumor.

Treatment and study plan

Primary outcomes

Sleep disturbance in a cohort of pediatric brain tumor survivors.

Time frame: 2 years
- 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.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2013
First posted: Apr 13, 2010
Registry last updated: Nov 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed