Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT07201935
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thermodynamic Exposure and Sleep in Military Cadets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glymphatic clearance', 'timeFrame': 'End of baseline monitoring phase (Day 7), end of intervention week 1 (Day 14), and end of intervention (Day 28)', 'description': 'Changes in parenchymal resistance during sleep'}, {'measure': 'Sleep Efficiency', 'timeFrame': 'Each night of the baseline monitoring period (7days) and intervention phase (14days)', 'description': 'Percentage of sleep period spent asleep measured by the Oura Ring (percentage, %)'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'At the end of the baseline monitoring phase (Day 7), end of intervention week 1 (Day 14), and end of intervention phase (Day 28)', 'description': 'Self-reported sleep quality'}, {'measure': 'Profile of Mood States: Total Mood Disturbance', 'timeFrame': 'At the end of the baseline monitoring phase (Day 7), end of intervention week 1 (Day 14), and end of intervention phase (Day 28)', 'description': 'Self-reported mood disturbance used by summing all negative profiled mood sub-scores (tension, depression, anger/hostility, fatigue, and confusion) and subtracting the positive profiled mood sub-score (vigor). (score -32 - 200, higher equals greater mood disturbance)'}], 'secondaryOutcomes': [{'measure': 'Total Sleep Duration', 'timeFrame': 'Each night of the baseline monitoring period (7days) and intervention phase (14days)', 'description': 'Total duration of sleep period measured by the Oura Ring (seconds, s)'}, {'measure': 'REM Sleep Duration', 'timeFrame': 'Each night of the baseline monitoring period (7days) and intervention phase (14days)', 'description': 'Duration of sleep period spent in REM sleep measured by the Oura Ring (seconds, s)'}, {'measure': 'Deep Sleep Duration', 'timeFrame': 'Each night of the baseline monitoring period (7days) and intervention phase (14days)', 'description': 'Duration of sleep periods spent in deep (N3) sleep (seconds, s)'}, {'measure': 'Light Sleep Duration', 'timeFrame': 'Each night of the baseline monitoring period (7days) and intervention phase (14days)', 'description': 'Duration of sleep period spent in light (N1 or N2) sleep (seconds, s)'}, {'measure': 'Restless Sleep Duration', 'timeFrame': 'Each night of the baseline monitoring period (7days) and intervention phase (14days)', 'description': 'Duration of sleep period with increased registered movements as measured by the Oura Ring (seconds, s)'}, {'measure': 'Wake After Sleep Onset (WASO) Duration', 'timeFrame': 'Each night of the baseline monitoring period (7days) and intervention phase (14days)', 'description': 'Total time spent awake after falling asleep (seconds, s)'}, {'measure': 'RMSSD', 'timeFrame': 'Each night of the baseline monitoring period (7days) and intervention phase (14days)', 'description': 'Root mean squared of temporal latency between successive heart beats throughout sleep period measured by the Oura Ring (milliseconds, ms)'}, {'measure': 'Nighttime Skin Temperature', 'timeFrame': 'Each night of the baseline monitoring period (7days) and intervention phase (14days)', 'description': 'Skin temperature (degrees Celsius, C°) throughout sleep period measured by the Oura Ring.'}, {'measure': 'Profile of Mood States: Tension/Anxiety', 'timeFrame': 'End of baseline monitoring period (Day 7), end of intervention week 1 (Day 14), and end of intervention (Day 28).', 'description': 'Tension/Anxiety sub-score computed from the POMS (score 0 - 36, higher equals more tension/anxiety)'}, {'measure': 'Profile of Mood States: Depression', 'timeFrame': 'End of baseline monitoring period (Day 7), end of intervention week 1 (Day 14), and end of intervention (Day 28)', 'description': 'Depression sub-score from the POMS (score 0 - 60, higher equals greater depression)'}, {'measure': 'Profile of Mood States: Anger/Hostility', 'timeFrame': 'End of baseline monitoring period (Day 7), end of intervention week 1 (Day 14), and end of intervention (Day 28)', 'description': 'Anger/Hostility sub-score from the POMS (score 0 - 48, higher equals greater anger/hostility)'}, {'measure': 'Profile of Mood States: Vigor', 'timeFrame': 'End of baseline monitoring period (Day 7), end of intervention week 1 (Day 14), and end of intervention (Day 28)', 'description': 'Vigor sub-score from the POMS (score 0 - 32, higher equals more vigor)'}, {'measure': 'Profile of Mood States: Fatigue', 'timeFrame': 'End of baseline monitoring period (Day 7), end of intervention week 1 (Day 14), and end of intervention (Day 28)', 'description': 'Fatigue sub-score from the POMS (score 0 - 28, higher equals more fatigue)'}, {'measure': 'Profile of Mood States: Confusion', 'timeFrame': 'End of baseline monitoring period (Day 7), end of intervention week 1 (Day 14), and end of intervention (Day 28)', 'description': 'Confusion sub-score from the POMS (score 0 - 28, higher equals more confusion)'}, {'measure': 'Sleep Time Heart Rate', 'timeFrame': 'Each night of the baseline monitoring period (7days) and intervention phase (14days)', 'description': 'Average heart rate during sleep (beats per minute, bpm)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glymphatic System', 'Sleep quality', 'Sleep architecture', 'Thermodynamic exposure'], 'conditions': ['Cold-water Immersion', 'High Heat Sauna', 'Combination of Cold-water Immersion and High Heat Sauna']}, 'descriptionModule': {'briefSummary': 'This pilot study investigates the effects of cold-water immersion, traditional sauna use, and their combination on sleep architecture, glymphatic clearance, and psycho-affective health in military cadets. The study uses wearable technologies including the Oura Ring and the Applied Cognition Glymphatic Monitor to collect objective sleep and physiological data.', 'detailedDescription': 'The study will enroll 45 military cadets from The Citadel Military College, randomized into three groups: Cold-Water Immersion (CWI), High Heat Sauna (HHS), and Combined (COM). Participants will undergo a 7-day baseline period followed by a 14-day intervention. Sleep architecture, glymphatic function, and psycho-affective health will be assessed using validated wearable devices and questionnaires. The study aims to identify intervention-specific improvements in sleep and glymphatic clearance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 30 years of age\n* Member of the Ranger Challenge group at The Citadel.\n* Access to a smartphone with access to appropriate app marketplace (Apple iOS 15, Android 8.0 or newer) and reliable data access.\n* Ability to access and operate Oura Ring application\n\nExclusion Criteria:\n\n* Medical contraindications to continuous wearing of the Oura Ring.\n* Current diagnosis of neurological, cardiovascular, and/or sleep disorder.'}, 'identificationModule': {'nctId': 'NCT07201935', 'briefTitle': 'Thermodynamic Exposure and Sleep in Military Cadets', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Hot, Cold, and Combined Thermodynamic Exposure to Improve Sleep Quality and Sleep-Time Glymphatic Clearance Among Military Cadets', 'orgStudyIdInfo': {'id': 'Pro00147353'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cold-water immersion', 'description': '5 minutes of cold-water immersion (submerged up to chin) at 8 - 10C°(46.4 - 50F°) in the morning between 6:00 - 8:00am.', 'interventionNames': ['Behavioral: Cold Water Immersion']}, {'type': 'EXPERIMENTAL', 'label': 'High heat sauna', 'description': '20 minutes of high heat sauna at 90 - 94C° (190 - 201.2F°) between 5:00 - 7:00pm', 'interventionNames': ['Behavioral: High Heat Sauna']}, {'type': 'EXPERIMENTAL', 'label': 'Combination', 'description': '5 minutes of cold-water immersion (submerged up to chin) at 8 - 10C°(46.4 - 50F°) in the morning between 6:00 - 8:00am and 20 minutes of high heat sauna at 90 - 94C° (190 - 201.2F°) between 5:00 - 7:00pm', 'interventionNames': ['Behavioral: Cold Water Immersion', 'Behavioral: High Heat Sauna']}], 'interventions': [{'name': 'Cold Water Immersion', 'type': 'BEHAVIORAL', 'description': 'Participants will complete 14 daily sessions of cold-water immersion exposure.', 'armGroupLabels': ['Cold-water immersion', 'Combination']}, {'name': 'High Heat Sauna', 'type': 'BEHAVIORAL', 'description': 'Participants will complete 14 evening sessions in the high heat sauna', 'armGroupLabels': ['Combination', 'High heat sauna']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29404', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'contacts': [{'name': 'Geoffery Mcleod, DO', 'role': 'CONTACT', 'email': 'mcleodge@musc.edu', 'phone': '843-953-4827'}], 'facility': 'The Citadel Military College', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Mark Rosenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}