Sleep Circadian RhythmsNCT04669574
Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients
An observational study of Sleep Circadian Rhythms and Chronodisruption, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sleep Circadian Rhythms, Chronodisruption
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 9 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -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 locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients: An Observational Study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Sleep Circadian Rhythms, Chronodisruption
- Keywords
- Sleep Disturbance, smart wearable, Patient-Reported Outcomes, Natural History
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: End of Study
Secondary outcomes (6)
Measure correlation between physiological sleep data and self-reported sleep questionnaires
To access the correlation between physiological sleep data collected from smart wearables with a self-reported sleep disturbance (SD) instruments (PROMIS - Sleep Related Impairment (SRI)).
Measured: End of Study
Measure sleep onset latency and sleep quality, efficiency and architecture
To assess physiological sleep measurements attained from smart wearables, including daytime sleepiness (as measured by daytime napping duration/number, sleep onset latency [SOL] and Rapid Eye Movement Latency [RL]) and sleep quality (as measured by total sleep time [TST], Wake After Sleep Onset [WASO], Sleep Efficiency [SE] and sleep architecture - Awake, Rapid Eye Movement [REM], Light or Deep Slow Wave Sleep [SWS])
Measured: End of Study
Measure comparability of clinical evaluation and at-home collection with sleep data from self-reported PROMIS questionnaires
To determine if reported quality of sleep collected with the PROMIS Sleep Indices are comparable between clinical evaluation and collection at-home.
Measured: End of Study
Measure if patient chronotype is more pronounced in individuals with circadian disruption as measured by smart wearables
To determine if patient chronotype, as measured by the Morningness-Eveningness Questionnaire (MEQ), are more pronounced in individuals with circadian disruption as measured by smart wearables
Measured: End of Study
Measure if patient chronotype is more pronounced in individuals with sleep disturbance as measured by smart wearables
To determine if patient chronotype, as measured by the Morningness-Eveningness Questionnaire (MEQ), are more pronounced in individuals with sleep disturbance as measured by smart wearables
Measured: End of Study
Measure circadian rhythm variables to see if they dampen in patients with moderate to severe levels of sleep disturbances
To determine if circadian rhythm variables (Amplitude and Phase onset/offset) are dampened or phase shifted in patients with moderate to severe levels of sleep disturbances (as measured by the MDASI-BT, score of >=5).
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start29 Jun 2021
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sleep Circadian RhythmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tito R Mendoza, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669574
- Sponsor's protocol ID
- 10000085
- Other IDs
- 000085-C
- Status last verified
- 11 Jun 2025
- First submitted
- 15 Dec 2020
- Last updated
- 2 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Publications
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.
PubMed 31386001Cook 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.
PubMed 28448949Armstrong 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.
PubMed 27286798
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients: An Observational Study
- ClinicalTrials.gov ID
- NCT04669574
- Acronym / sponsor ID
- 10000085
- Conditions
- Sleep Circadian Rhythms, Chronodisruption
- Keywords
- Sleep Disturbance, smart wearable, Patient-Reported Outcomes, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -Participants who are unwilling or unable to synchronize or link their Fitbit smart wearable device to their personal smart phone or another compatible device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants who wore the Fitbit device and complete questionnaires
Time frame: End of Study
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
6 secondary outcomes
Measure correlation between physiological sleep data and self-reported sleep questionnaires
Time frame: End of Study
Measure sleep onset latency and sleep quality, efficiency and architecture
Time frame: End of Study
Measure comparability of clinical evaluation and at-home collection with sleep data from self-reported PROMIS questionnaires
Time frame: End of Study
Measure if patient chronotype is more pronounced in individuals with circadian disruption as measured by smart wearables
Time frame: End of Study
Measure if patient chronotype is more pronounced in individuals with sleep disturbance as measured by smart wearables
Time frame: End of Study
Measure circadian rhythm variables to see if they dampen in patients with moderate to severe levels of sleep disturbances
Time frame: End of Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Background: PubMed 31386001Armstrong 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.
- Background: PubMed 28448949Cook 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.
- Background: PubMed 27286798Armstrong 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tito R Mendoza, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Circadian Rhythms and Chronodisruption, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who wore the Fitbit device and complete questionnaires (time frame: End of Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04669574, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.