Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients

NCT04669574 | Completed

• 2 other identifiers: 10000085000085-C
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Sleep Circadian Rhythms; Chronodisruption

Keywords

Sleep Disturbance; smart wearable; Patient-Reported Outcomes; Natural History

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Measure correlation between physiological sleep data and self-reported sleep questionnaires

  End of Study

• Measure sleep onset latency and sleep quality, efficiency and architecture

  End of Study

• Measure comparability of clinical evaluation and at-home collection with sleep data from self-reported PROMIS questionnaires

  End of Study

• Measure if patient chronotype is 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

  End of Study

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Participants who are unwilling or unable to synchronize or link their Fitbit smart wearable device to their personal smart phone or another compatible device.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 31386001 BACKGROUND

• 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.

  PMID: 28448949 BACKGROUND

• 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.

  PMID: 27286798 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Tito R Mendoza, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 17, 2020
• Study Start: June 29, 2021
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: July 2, 2025

Record last verified: 2025-06-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.@@@@@@All collected IPD will be available after primary analysis have been published.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (1)