Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2021-11-30
2022-02-05
Brief Summary
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Detailed Description
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Participants will be given a Fitbit device that measures the time of sleep and stages of sleep. Data from the Fitbit are synced to the participant's smart phone. Participants will complete the Single-Quality of Sleep (SQS) scale questionnaire on a daily basis. This questionnaire will be sent to participants on a daily basis via email. This questionnaire is a simple 0-10 rating scale of the quality of their sleep. Participants will then receive the Bedjet cooling sleep system and use it for 10 days to become acclimatized to it. Then they will use the Bedjet for 28 more days, while again completing the daily SQS. This is not a randomized trial, but rather a before-and-after trial.
Changes in mean daily sleep score, SQS from control and intervention time periods will be computed. Subjective measures of participant's satisfaction with the Bedjet system will also be obtained.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Bedjet arm
All participants will complete a baseline study period of 4 weeks and then will be provided the Bedjet system.
Bedjet
Bedjet is a sleep cooling system. All participants will be provided a Bedjet system as part of the study.
FitBit
Each participant will receive a FitBit device to track sleep quality and related information.
Interventions
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Bedjet
Bedjet is a sleep cooling system. All participants will be provided a Bedjet system as part of the study.
FitBit
Each participant will receive a FitBit device to track sleep quality and related information.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Fitbit LLC
INDUSTRY
University of Massachusetts, Worcester
OTHER
Responsible Party
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Steven Bird
Professor
Locations
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UMassMemorial Health Care
Worcester, Massachusetts, United States
Countries
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Other Identifiers
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H00023479
Identifier Type: -
Identifier Source: org_study_id
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