Use of a Sleep System to Improve Sleep

Sleep Clinical Trial

Official title:

Bed Cooling System to Effect Better Sleep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05175456
• Other study ID #: H00023479
• Status: Completed
• Phase: N/A
• Start date: November 30, 2021
• Est. completion date: February 5, 2022

Study information

• Verified date: February 2022
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: February 5, 2022
• Est. primary completion date: February 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Sleep

Intervention

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

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

Locations

Country	Name	City	State
United States	UMassMemorial Health Care	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Fitbit Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Quality Scale change	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)	after 4 weeks
Primary	Fitbit Sleep Score	change in average Fitbit Sleep Score from before and after implementation of the Bedjet	4 weeks before Bedjet system and the 4 weeks after