Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients

Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients: An Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Sleep Circadian Rhythms; Chronodisruption

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, 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.

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

cohort selection will be from Primary Brain Tumor patients enrolled onto the Natural History Study (16C0151) at the Neuro-Oncology Branch and all tumor types and grades are eligible.

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Group 1; Participants who are newly diagnosed and have initiated front-line treatment.
Group 2; Participants who have previously had one progression.
Group 3; Participants who have previously had a second recurrence.
Group 4; Participants who are on imaging surveillance and not receiving anti-neoplastic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who wore the Fitbit device and complete questionnaires	To describe the feasibility of using smart wearable devices, which quantify sleep stages, heart rate and activity, to measure the impact of oncologic therapy on sleep and circadian rhythms in the PBT population across disease trajectory	End of Study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure correlation between physiological sleep data and self-reported sleep questionnaires	To access the correlation between physiological sleep data collected from smart wearables with a self-reported sleep disturbance (SD) instruments (PROMIS - Sleep Related Impairment (SRI)).	End of Study
Measure sleep onset latency and sleep quality, efficiency and architecture	To assess physiological sleep measurements attained from smart wearables, including daytime sleepiness (as measured by daytime napping duration/number, sleep onset latency [SOL] and Rapid Eye Movement Latency [RL]) and sleep quality (as measured by total sleep time [TST], Wake After Sleep Onset [WASO], Sleep Efficiency [SE] and sleep architecture - Awake, Rapid Eye Movement [REM], Light or Deep Slow Wave Sleep [SWS])	End of Study
Measure comparability of clinical evaluation and at-home collection with sleep data from self-reported PROMIS questionnaires	To determine if reported quality of sleep collected with the PROMIS Sleep Indices are comparable between clinical evaluation and collection at-home.	End of Study
Measure if patient chronotype is more pronounced in individuals with circadian disruption as measured by smart wearables	To determine if patient chronotype, as measured by the Morningness-Eveningness Questionnaire (MEQ), are more pronounced in individuals with circadian disruption as measured by smart wearables	End of Study
Measure if patient chronotype is more pronounced in individuals with sleep disturbance as measured by smart wearables	To determine if patient chronotype, as measured by the Morningness-Eveningness Questionnaire (MEQ), are more pronounced in individuals with sleep disturbance as measured by smart wearables	End of Study
Measure circadian rhythm variables to see if they dampen in patients with moderate to severe levels of sleep disturbances	To determine if circadian rhythm variables (Amplitude and Phase onset/offset) are dampened or phase shifted in patients with moderate to severe levels of sleep disturbances (as measured by the MDASI-BT, score of >=5).	End of Study

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Tito R Mendoza, Ph.D., National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Armstrong TS, Shade MY, Breton G, Gilbert MR, Mahajan A, Scheurer ME, Vera E, Berger AM. Sleep-wake disturbance in patients with brain tumors. Neuro Oncol. 2017 Mar 1;19(3):323-335. doi: 10.1093/neuonc/now119.
• Armstrong TS, Vera E, Zhou R, Acquaye AA, Sullaway CM, Berger AM, Breton G, Mahajan A, Wefel JS, Gilbert MR, Bondy M, Scheurer ME. Association of genetic variants with fatigue in patients with malignant glioma. Neurooncol Pract. 2018 May;5(2):122-128. doi: 10.1093/nop/npx020. Epub 2017 Sep 19.
• Cook JD, Prairie ML, Plante DT. Utility of the Fitbit Flex to evaluate sleep in major depressive disorder: A comparison against polysomnography and wrist-worn actigraphy. J Affect Disord. 2017 Aug 1;217:299-305. doi: 10.1016/j.jad.2017.04.030. Epub 2017 Apr 19.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2021
• Primary Completion (Actual): December 9, 2024
• Study Completion (Actual): December 9, 2024

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: June 11, 2025

More Information

Terms related to this study

• Keywords: Natural History; Patient-Reported Outcomes; Sleep Disturbance; smart wearable
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 10000085; 000085-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD recorded in the medical record will be shared with intramural investigators upon request.
• IPD Sharing Time Frame: Clinical data available during the study and indefinitely.@@@@@@All collected IPD will be available after primary analysis have been published.
• IPD Sharing Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No