Clinical trial · Observational
Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients
Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients: An Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronodisruption | — | UNRESOLVED | — |
| Sleep Circadian Rhythms | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Group 1
- description
- Participants who are newly diagnosed and have initiated front-line treatment.
- label
- Group 2
- description
- Participants who have previously had one progression.
- label
- Group 3
- description
- Participants who have previously had a second recurrence.
- label
- Group 4
- description
- Participants who are on imaging surveillance and not receiving anti-neoplastic treatment
Primary outcomes (1)
- measure
- Number of participants who wore the Fitbit device and complete questionnaires
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
* 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.
References
Publications (3)
- BACKGROUNDArmstrong 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
- BACKGROUNDCook 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
- BACKGROUNDArmstrong 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