Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients

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, 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 population.

Objectives:

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.

Eligibility:

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 (>=18 years of age) who are English-speaking and able to self-report symptoms.

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 or another compatible device are excluded

Design:

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.

• 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.