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NCT04669574 · ClinicalTrials.gov registry record
Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 101
- Enrollment target
NCT04669574: Completed study, sponsored by National Cancer Institute (NCI).
NCT04669574 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 101 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04669574 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 101 participants
- Enrollment target
Study 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.
Primary Outcome
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2021-06-29 |
| Est. Completion | 2024-12-09 |
What the finished NCT04669574 record still lists
NCT04669574 is an observational study that tracks outcomes without assigning an intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04669574 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04669574 about?
NCT04669574 is a clinical study titled "Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients". 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 mor...
What is the current status of trial NCT04669574?
This trial is currently completed. The enrollment target is 101 participants. The study started on 2021-06-29. Estimated completion is 2024-12-09.
Who is sponsoring clinical trial NCT04669574?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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