Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT03446820
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2018-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
This Study Assesses the Impact of Different Sheets on Body Temperature and Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Participants will be randomly assigned to sleep in the residential module of the Well Living Lab. One week will be with standard sheets, followed by one week of hygro cotton sheets.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-08', 'studyFirstSubmitDate': '2018-02-21', 'studyFirstSubmitQcDate': '2018-02-23', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body temperature', 'timeFrame': '1 night', 'description': 'body temperature collected via body sensors'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep']}, 'descriptionModule': {'briefSummary': 'Thermal comfort and subsequent sleep quality will improve with the use of bedding that incorporates thermoregulation technology, in comparison to standard bedding products.', 'detailedDescription': 'Participants will spend nights sleeping in the residential module of the Well Living Lab. Participants will cross over from normal sheets to hygro cotton sheets to assess impact of different sheet types on microclimate (e.g. temperature) and the impact on sleep quality.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'Premenopausal women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria. Premenopausal women Age 21-45\n\nExclusion Criteria History of sleep disorders'}, 'identificationModule': {'nctId': 'NCT03446820', 'briefTitle': 'This Study Assesses the Impact of Different Sheets on Body Temperature and Sleep', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Sleep Quality and Microclimate Study', 'orgStudyIdInfo': {'id': '18-000832'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sleep participants', 'description': 'Crossover from standard sheets to hygro cotton sheets', 'interventionNames': ['Other: hygro cotton sheets']}], 'interventions': [{'name': 'hygro cotton sheets', 'type': 'OTHER', 'description': 'hygro cotton sheets will be utilized to impact microclimate', 'armGroupLabels': ['Sleep participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Brent A Bauer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Brent A. Bauer', 'investigatorAffiliation': 'Mayo Clinic'}}}}