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Assessment of Sleep Complaints in Brain Tumor Survivors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01102998
First received: April 12, 2010
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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
Brain Tumors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Sleep Complaints in Brain Tumor Survivors

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Sleep disturbance in a cohort of pediatric brain tumor survivors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    • 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.


Enrollment: 153
Study Start Date: April 2010
Study Completion Date: April 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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)
  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children ages 8 to 18 years of age who are patients at St Jude Children's Research Hospital and are at least 5 years from diagnosis and at least 2 years post treatment or observation only for a brain tumor were targeted to assess the prevalence of sleep complaints.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102998

Locations
United States, Tennessee
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
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01102998     History of Changes
Other Study ID Numbers: PBTSLP
Study First Received: April 12, 2010
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Sleep complaints
Brain Tumor Survivors

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014