Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT05175456
Status:
COMPLETED
Last Update Posted:
2022-03-07
First Post:
2021-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of a Sleep System to Improve Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-18', 'studyFirstSubmitDate': '2021-12-14', 'studyFirstSubmitQcDate': '2021-12-14', 'lastUpdatePostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep Quality Scale change', 'timeFrame': 'after 4 weeks', 'description': '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)'}, {'measure': 'Fitbit Sleep Score', 'timeFrame': '4 weeks before Bedjet system and the 4 weeks after', 'description': 'change in average Fitbit Sleep Score from before and after implementation of the Bedjet'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nParticipants 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.\n\nChanges 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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).\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05175456', 'briefTitle': 'Use of a Sleep System to Improve Sleep', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Bed Cooling System to Effect Better Sleep', 'orgStudyIdInfo': {'id': 'H00023479'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bedjet arm', 'description': 'All participants will complete a baseline study period of 4 weeks and then will be provided the Bedjet system.', 'interventionNames': ['Other: Bedjet', 'Device: FitBit']}], 'interventions': [{'name': 'Bedjet', 'type': 'OTHER', 'description': 'Bedjet is a sleep cooling system. All participants will be provided a Bedjet system as part of the study.', 'armGroupLabels': ['Bedjet arm']}, {'name': 'FitBit', 'type': 'DEVICE', 'description': 'Each participant will receive a FitBit device to track sleep quality and related information.', 'armGroupLabels': ['Bedjet arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655-0002', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMassMemorial Health Care', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fitbit LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Steven Bird', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}