MedTrace Logo

Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients

NCT04669574 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 101

Last updated 2025-07-02

No results posted yet for this 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.

Conditions

  • Sleep Circadian Rhythms
  • Chronodisruption

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Tito R Mendoza, Ph.D. · National Cancer Institute (NCI)

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2024-12-09
Completion
2024-12-09

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04669574 on ClinicalTrials.gov