Assessment of Sleep Complaints in Brain Tumor Survivors
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| City: |
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Memphis |
| State: |
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Tennessee |
| Zip Code: |
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38105 |
| Conditions: |
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Brain Tumors |
| Purpose: |
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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
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| Study Summary: |
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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
- Treatment modality (surgery, radiation therapy, and/or chemotherapy vs. observation
only)
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| Criteria: |
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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.
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| NCT ID: |
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NCT01102998 |
| Primary Contact: |
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Principal Investigator
Valerie Crabtree, Ph.D
St. Jude Children's Research Hospital
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| Backup Contact: |
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N/A |
| Location Contact: |
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Memphis, Tennessee 38105
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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