Assessment of Sleep Complaints in Brain Tumor Survivors

Sponsor
St. Jude Children's Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01102998
Collaborator
(none)
153
1
36
4.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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)

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    153 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Sleep Complaints in Brain Tumor Survivors
    Study Start Date :
    Apr 1, 2010
    Actual Primary Completion Date :
    Sep 1, 2012
    Actual Study Completion Date :
    Apr 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Brain Tumor Survivors

    Brain tumor survivors ages 8 to 18 years who are at least 5 years post diagnosis and at least 2 years post active therapy or observation and their parents/guardians will be approached to participate during clinic visits.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St . Jude Children's Research Hospital Memphis Tennessee United States 38105

    Sponsors and Collaborators

    • St. Jude Children's Research Hospital

    Investigators

    • Principal Investigator: Valerie Crabtree, Ph.D, St. Jude Children's Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    St. Jude Children's Research Hospital
    ClinicalTrials.gov Identifier:
    NCT01102998
    Other Study ID Numbers:
    • PBTSLP
    First Posted:
    Apr 13, 2010
    Last Update Posted:
    Nov 18, 2013
    Last Verified:
    Nov 1, 2013
    Keywords provided by St. Jude Children's Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 18, 2013