Assessment of Sleep Complaints in Brain Tumor Survivors

Brain Tumors Clinical Trial

Official title:

Assessment of Sleep Complaints in Brain Tumor Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102998
• Other study ID #: PBTSLP
• Status: Completed
• Phase: N/A
• First received: April 12, 2010
• Last updated: November 15, 2013
• Start date: April 2010
• Est. completion date: April 2013

Study information

• Verified date: November 2013
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: April 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors

Locations

Country	Name	City	State
United States	St . Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years	No

External Links

•   St. Jude Children's Research Hospital