Sponsor study identifier
Secondary identifiers
observational
101
1 country
1
Study Start
June 29, 2021
Actual (reported)Primary Completion
December 9, 2024
Actual (reported)Study Completion
December 9, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 9, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 15, 2020
Actual (reported)December 17, 2020
Actual (reported)June 29, 2021
Actual (reported)December 9, 2024
Actual (reported)December 9, 2024
Actual (reported)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
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
Participants who are newly diagnosed and have initiated front-line treatment.
Participants who have previously had one progression.
Participants who have previously had a second recurrence.
Participants who are on imaging surveillance and not receiving anti-neoplastic treatment
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.
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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.
Tito R Mendoza, Ph.D.
National Cancer Institute (NCI)
101 participants (actual enrollment reported by the registry).
First Submitted
December 15, 2020
First Posted
December 17, 2020
Study Start
June 29, 2021
Actual (reported)Contact the study team to confirm eligibility.
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.
Primary Completion
December 9, 2024
Actual (reported)Study Completion
December 9, 2024
Actual (reported)Last Updated
July 2, 2025
Record last verified: 2025-06-11
All IPD recorded in the medical record will be shared with intramural investigators upon request.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: