Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients
NCT ID: NCT04669574
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
101 participants
OBSERVATIONAL
2021-06-29
2024-12-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Identifying Circadian Rest-Activity Rhythm Disorders in Patients With Advanced Cancer
NCT06023654
Sleep Hygiene Education, ReadiWatchTM Actigraphy, and Telehealth Cognitive Behavioral Training for Insomnia Effect, on Symptom Relief for Men With Prostate Cancer Receiving Androgen Deprivation Therapy
NCT05582759
Sleep and Immune Checkpoint Inhibitors
NCT04070651
Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients
NCT05099952
INvestigating the Value of Early Sleep Therapy
NCT06294041
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Participants who are newly diagnosed and have initiated front-line treatment.
No interventions assigned to this group
Group 2
Participants who have previously had one progression.
No interventions assigned to this group
Group 3
Participants who have previously had a second recurrence.
No interventions assigned to this group
Group 4
Participants who are on imaging surveillance and not receiving anti-neoplastic treatment
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tito R Mendoza, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
NIH Clinical Center Detailed Web Page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
000085-C
Identifier Type: -
Identifier Source: secondary_id
10000085
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.