Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 99 Years
Gender	All

More Inclusion & Exclusion Criteria

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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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04669574
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Cancer Institute (NCI)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Amanda L King, Ph.D.
Principal Investigator Affiliation	National Cancer Institute (NCI)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	NIH
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sleep Circadian Rhythms, Chronodisruption
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

: 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

Interventions

Contact a Trial Team

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Bethesda, Maryland

Status

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

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