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Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04669574
Recruitment Status : Enrolling by invitation
First Posted : December 17, 2020
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief 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. 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.

...


Condition or disease
Sleep Circadian Rhythms Chronodisruption

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients: an Observational Study
Actual Study Start Date : June 29, 2021
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Group/Cohort
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Measure correlation between physiological sleep data and self-reported sleep questionnaires [ Time Frame: End of Study ]
    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)).

  2. Measure sleep onset latency and sleep quality, efficiency and architecture [ Time Frame: End of Study ]
    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])

  3. Measure comparability of clinical evaluation and at-home collection with sleep data from self-reported PROMIS questionnaires [ Time Frame: End of Study ]
    To determine if reported quality of sleep collected with the PROMIS Sleep Indices are comparable between clinical evaluation and collection at-home.

  4. Measure if patient chronotype is more pronounced in individuals with circadian disruption as measured by smart wearables [ Time Frame: End of Study ]
    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

  5. Measure if patient chronotype is more pronounced in individuals with sleep disturbance as measured by smart wearables [ Time Frame: End of Study ]
    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

  6. Measure circadian rhythm variables to see if they dampen in patients with moderate to severe levels of sleep disturbances [ Time Frame: End of Study ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria
  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669574


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Terri S Armstrong, C.R.N.P. National Cancer Institute (NCI)
Additional Information:
Publications:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04669574    
Other Study ID Numbers: 10000085
000085-C
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 15, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Clinical data available during the study and indefinitely.@@@@@@All collected IPD will be available after primary analysis have been published.
Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Sleep Disturbance
smart wearable
Patient-Reported Outcomes
Natural History
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases