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OpenTrials
Completed

NCT Number: NCT05175456

Use of a Sleep System to Improve Sleep

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.

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Key information

Conditions

Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMassMemorial Health Care

Worcester, Massachusetts, 01655-0002, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Bedjet

Other

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

Fitbit

Device

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

Primary outcomes

  1. Sleep Quality Scale change

    Time frame: after 4 weeks

    change in average SQS from before and after time periods Sleep quality information will be evaluated using the Sleep Quality Scale (SQS), an [# of questions] survey that asks questions to obtain information regarding quality of sleep. The range of scores on the survey is [X] to [X], with [X] indicating poor sleep quality and (X] indicating good sleep quality. The outcome will reflect the change in score values from baseline (4 weeks) to post-use of BedJet (4 weeks)

  2. Fitbit Sleep Score

    Time frame: 4 weeks before Bedjet system and the 4 weeks after

    change in average Fitbit Sleep Score from before and after implementation of the Bedjet

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Fitbit LLC

Registry information

Official study title

Bed Cooling System to Effect Better Sleep

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 3, 2022
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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