Status:
COMPLETED
Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Sleep Circadian Rhythms
Chronodisruption
Eligibility:
All Genders
18-99 years
Brief Summary
Background: Sleep disturbances are among the most common and severe symptoms reported by people with primary brain tumors (PBT). Smart wearable devices like Fitbits may be able to give detailed data ...
Detailed Description
Background: Sleep disturbances are among the most common and severe symptoms reported in the Primary Brain Tumor (PBT)population and incidence rates are associated with oncologic therapies, particula...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects with histologically documented PBT
- PBT patients must be enrolled on the Natural History Study (NHS) trial 16C0151 in the Neuro-Oncology Branch (NOB). Note: Concurrent enrollment in other NOB trials is also permissible.
- Adults (greater than or equal to 18 years of age) who are English-speaking
- Participants must be able to self-report symptoms
- Ability of subject to understand and the willingness to sign a written consent document
- EXCLUSION CRITERIA:
- Participants who are unwilling or unable to synchronize or link their Fitbit smart wearable device to their personal smart phone or another compatible device.
Exclusion
Key Trial Info
Start Date :
June 29 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 9 2024
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04669574
Start Date
June 29 2021
End Date
December 9 2024
Last Update
July 2 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892