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Assessment of Sleep Complaints in Brain Tumor Survivors

Assessment of Sleep Complaints in Brain Tumor Survivors

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01102998
Enrollment
153
Registered
2010-04-13
Start date
2010-04-30
Completion date
2013-04-30
Last updated
2013-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumors

Keywords

Sleep complaints, Brain Tumor Survivors

Brief 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

Detailed description

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)

Interventions

None listed

Sponsors

St. Jude Children's Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sleep disturbance in a cohort of pediatric brain tumor survivors.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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026