Use of a Sleep System to Improve Sleep

NCT05175456 | Completed

• 1 other identifier: H00023479
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Bedjet arm

EXPERIMENTAL

All participants will complete a baseline study period of 4 weeks and then will be provided the Bedjet system.

Other: Bedjet; Device: FitBit

Interventions

Bedjet OTHER

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

Bedjet arm

FitBit DEVICE

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

Bedjet arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Fitbit LLC: collaborator

Study Sites (1)

UMassMemorial Health Care

Worcester, Massachusetts, 01655-0002, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 3, 2022
• Study Start: November 30, 2021
• Primary Completion: February 5, 2022
• Study Completion: February 5, 2022
• Last Updated: March 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)