Skip to main content

Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients

Trial Status: Enrolling by Invitation

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 about people s sleep and circadian rhythms. In this study, researchers will use Fitbits to learn more about sleep disruptions caused by tumors. This might help them design better future treatment and supportive care studies. Objective: To describe sleep disturbances and circadian disruption in people with PBT. Eligibility: English-speaking adults ages 18 and older who have PBT and are enrolled in the NIH study, Evaluation of the Natural History of and Specimen Banking for Patients with Tumors of the Central Nervous System. It is also known as the Natural History Study, trial #16C0151. Design: Participants will be screened over the telephone or in person. They will be asked about their medical history. Their cancer diagnosis will be confirmed through test results and pathology reports. Participants will complete 4 surveys. The surveys take about 20 minutes to complete and will ask about: The quality of their sleep Their ability to fall asleep and stay asleep How the quality of their sleep affects their daily activities Their sleep hygiene and preferences Participants will get a Fitbit. It looks like a watch and is worn on the wrist. They will connect the device to their smart phone to track sleep, heart rate, and activity. They will wear it for 1 month. Participants will keep a daily sleep diary for 1 week. It will be sent via an electronic link. They will also repeat 2 of the surveys. Participation will last for 1 month. ...

Inclusion Criteria

  • - 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

Maryland

Bethesda
National Institutes of Health Clinical Center
Status: ENROLLING_BY_INVITATION
Contact: National Cancer Institute Referral Office
Phone: 888-624-1937

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 (greater than or equal to 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 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.

Trial Phase Phase NA

Trial Type Not provided by clinicaltrials.gov

Lead Organization
National Cancer Institute

Principal Investigator
Terri Sue Armstrong

  • Primary ID 10000085
  • Secondary IDs NCI-2020-13872, 000085-C
  • Clinicaltrials.gov ID NCT04669574