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Use of a Sleep System to Improve Sleep

Bed Cooling System to Effect Better Sleep

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05175456
Enrollment
59
Registered
2022-01-03
Start date
2021-11-30
Completion date
2022-02-05
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

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.

Detailed 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.

Interventions

OTHERBedjet

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

DEVICEFitBit

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

Sponsors

Fitbit LLC
CollaboratorINDUSTRY
University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Sleep Quality Scale changeafter 4 weekschange 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)
Fitbit Sleep Score4 weeks before Bedjet system and the 4 weeks afterchange in average Fitbit Sleep Score from before and after implementation of the Bedjet

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026