Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT05186233
Status:
COMPLETED
Last Update Posted:
2025-06-08
First Post:
2021-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Consumer Sleep Technology to Treat Shift Work Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010789', 'term': 'Phototherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2021-12-15', 'studyFirstSubmitQcDate': '2022-01-06', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dim light melatonin onset', 'timeFrame': 'Within two days of treatment for a duration of 24 hours', 'description': 'Melatonin values will be measured in saliva samples, collected in dim light conditions in a laboratory, to determine circadian phase.'}], 'secondaryOutcomes': [{'measure': 'Insomnia', 'timeFrame': 'Within one week of post-treatment', 'description': 'Insomnia will be measured with the Insomnia Severity Scale (0 to 28; higher scores correspond to worse severity)'}, {'measure': 'Daytime sleepiness', 'timeFrame': 'Within one week of post-treatment', 'description': 'Sleepiness will be measured with the Epworth Sleepiness Scale (0 to 24; a score of 10 or greater indicates excessive daytime sleepiness)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shift-work Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effectiveness of a personalized light exposure schedule for Shift Work Disorder (SWD) in night shift workers compared to a non-personalized light exposure schedule.', 'detailedDescription': 'Participants will be randomized into each condition (n = 25) in a 1:1 ratio. Variables of interest, dim light melatonin onset (DLMO) and shift work disorder (SWD) symptoms, will be assessed before and after the intervention, which will last two weeks. All participants (N=50) will be asked to wear an Apple Watch for two weeks leading up to an in-lab visit. Activity data collection from the Apple Watch will be processed through a mathematical model of the human circadian pacemaker (previously validated in SWD) to generate estimates of DLMO. This two-week period is followed by a 27-hour laboratory visit for pre-treatment assessment of DLMO (hourly saliva melatonin samples over 24 hours). At the end of this visit, participants will receive an orientation to the SHIFT mobile application, where they will be able to assess their prescribed light exposure schedule.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must work at least 2 night shifts a week\n* Participants must have night shifts starting between 18:00 and 02:00 and lasting 8 to 12 hours\n* Participants must have maintained this night shift schedule for at least 6 months\n* Participants must have Shift Work Disorder, diagnosed based on ICSD-3 criteria\n\nExclusion Criteria:\n\n* Medical history of central nervous system disorders\n* Medical history of other sleep disorders\n* Diagnosis of an unstable major medical condition medical chart review\n* Dependence on alcohol (≥ 4 beverages a day)\n* Heavy tobacco use (≥ 10 cigarettes per day)\n* Recreational drug use\n* Use of medications impacting central nervous system functioning\n* Caffeine use in excess of 5-6 servings (\\~ 600mg) per day\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05186233', 'acronym': 'SHIFT', 'briefTitle': 'Use of Consumer Sleep Technology to Treat Shift Work Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Innovations in Wearable Technology for Correcting Circadian Misalignment in Shift Work Disorder', 'orgStudyIdInfo': {'id': '15108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-personalized light condition', 'description': 'Participants will receive light exposure recommendations from the SHIFT mobile application based on their habitual sleep schedule. Participants will follow these recommendations over the course of two weeks.', 'interventionNames': ['Behavioral: Phototherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Personalized light condition', 'description': 'Participants will receive light exposure recommendations from the SHIFT mobile application based on their activity levels. Participants will follow these recommendations over the course of two weeks.', 'interventionNames': ['Behavioral: Phototherapy']}], 'interventions': [{'name': 'Phototherapy', 'type': 'BEHAVIORAL', 'description': 'Light exposure recommendations provided by SHIFT mobile application', 'armGroupLabels': ['Non-personalized light condition', 'Personalized light condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48377', 'city': 'Novi', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Columbus Medical Center', 'geoPoint': {'lat': 42.48059, 'lon': -83.47549}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Request for data sharing will be evaluated on a case-by-case basis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Academy of Sleep Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Scientist', 'investigatorFullName': 'Philip Cheng', 'investigatorAffiliation': 'Henry Ford Health System'}}}}