Use of a Sleep System to Improve Sleep

NCT ID: NCT05175456

Last Updated: 2022-03-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-02-05

Brief Summary

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The purpose of this study is to determine the effect of a bed cooling system on subjective and objective measures of sleep in physicians who work rotating shifts. The intent of the Investigators is to perform a before-and-after trial of a bed cooling system and determine the effects of that cooling system on sleep.

Detailed Description

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All practicing providers (residents, APPs, and attendings) in the Departments/Divisions of emergency medicine, Ob/Gyn, hospital medicine and family medicine will be offered participation in the study via an email invitation.

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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Sleep

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Bedjet

Intervention Type OTHER

Bedjet is a sleep cooling system. All participants will be provided a Bedjet system as part of the study.

FitBit

Intervention Type DEVICE

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.

Intervention Type OTHER

FitBit

Each participant will receive a FitBit device to track sleep quality and related information.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Residents, Fellows, Clinical Faculty and Advanced Practice Providers (APPs) of UMass Memorial/UMass Medical School who work rotating shifts or nightshifts in Emergency Medicine, Ob/Gyn, Hospital Medicine, or Family Medicine are eligible to participate (pregnant women are also eligible).

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fitbit LLC

INDUSTRY

Sponsor Role collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Steven Bird

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UMassMemorial Health Care

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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H00023479

Identifier Type: -

Identifier Source: org_study_id

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