Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients
- - 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
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,
particularly radiotherapy. Smart wearable devices have the potential to provide detailed
information about sleep and circadian rhythms in human subjects with lower potential for data
loss, as devices sync automatically and require less charging time. Measurement of sleep
through smart wearables, also eliminates the difficulties of recording in a sleep clinic and
allows for longer monitoring periods. Previous smart wearable research in healthy controls
has found that the Fitbit Charge 3TM model performs better than actigraphy and is the most
comparable to polysomnography, the gold standard of sleep detection. Currently, there are
very few studies examining sleep or circadian rhythms with these devices in the PBT
-To assess detection of sleep disturbances in PBT patients using the physiological sleep
measurements attained from smart wearable devices, as well as, the correlation with
self-reported sleep instruments.
- PBT patients must be enrolled on the Natural History Study (NHS) trial in the
Neuro-Oncology Branch (NOB) (all tumor types and grades eligible).
- Participants with histologically documented PBT.
- Concurrent enrollment in other NOB trials is permissible.
- Ability of subject to understand and the willingness to sign a written consent document.
- Adults (greater than or equal to 18 years of age) who are English-speaking and able to
- Exclude participants without tissue diagnosis.
- Participants who are unwilling or unable to synchronize or link their Fitbit smart
wearable device to their personal smart phone are excluded
- A total of 160 PBT participants will participate in this observational study.
- Participants will be sampled in a cross-sectional design at 1 of 4 timepoints across the
disease course. The study will collect sleep, activity and heart rate information over a
one-month period via Fitbit wearable device, which will be provided to patients at no
cost. This data includes fine measurements of sleep including sleep stages, latency,
fragmentation and efficiency, as well as, daytime napping duration and bout number.
Additionally, circadian rhythms parameters will be calculated to determine features
associated with chronodisruption including amplitude dampening, precision of rhythm
onset/offset, and rhythm stability. The study will also include the collection of
established self-reported patient reported outcome (PRO) measures for sleep and
circadian rhythms. Participants will be given sleep diaries to be completed at-home for
the fourth week of recording and will be asked to fill out the PRO measures during that
fourth week at the completion of the study.
- Descriptive statistics, T-tests, Wilcoxon rank sum tests, and multiple logistic
regression models will be used to evaluate the feasibility of the Fitbit device for
measuring sleep disturbance and circadian disruption in participants. Pearson or
Spearman correlations will be used to evaluate the relationship between the Fitbit
wearable biological measures of sleep and circadian rhythms and self-reported PROs.
Trial Phase Phase NA
Trial Type Not provided by clinicaltrials.gov
National Cancer Institute
Terri Sue Armstrong
- Primary ID 10000085
- Secondary IDs NCI-2020-13872, 000085-C
- Clinicaltrials.gov ID NCT04669574