Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-30 @ 7:03 PM
Study NCT ID:
NCT04652895
Status:
COMPLETED
Last Update Posted:
2021-12-20
First Post:
2020-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-24', 'size': 271295, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-29T11:58', 'hasProtocol': True}, {'date': '2020-09-11', 'size': 189891, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-09-29T11:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-17', 'studyFirstSubmitDate': '2020-10-16', 'studyFirstSubmitQcDate': '2020-12-02', 'lastUpdatePostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anxiety', 'timeFrame': '48 hours', 'description': 'self-reported anxiety survey'}], 'secondaryOutcomes': [{'measure': 'heart rate variability', 'timeFrame': '48 hours', 'description': 'Skin biosensor on patient chest, measuring heart rate over 6 minute interval while patient is awake and resting. Then heart rate variability is calculated based on the R-R interval.'}, {'measure': 'sleep', 'timeFrame': '48 hours', 'description': 'self-reported sleep survey. Also skin biosensor measuring heart rate and accelerometer overnight for 2 consecutive nights. Total sleep time and awakening episodes will be derived from the biosensor data.'}, {'measure': 'post-traumatic stress disorder (PTSD)', 'timeFrame': '48 hours', 'description': 'self-reported survey of PTSD symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart rate variability', 'sleep'], 'conditions': ['Traumatic Brain Injury', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'The investigators predict that decreased heart rate variability and poor sleep quality will be significantly correlated with higher self-reported anxiety following brain injury.', 'detailedDescription': 'Acute rehabilitation inpatients with moderate-to-severe brain injury will wear biosensors that track total sleep time and heart-rate variability for up to 1 week. During this time the participants will also complete surveys regarding symptoms of anxiety. The investigators hypothesize that decreased heart rate variability and poor sleep quality will be significantly correlated with higher self-reported anxiety following brain injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'moderate to severe traumatic brain injury inpatients in acute rehabilitation hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* traumatic brain injury\n* injury within past 6 months\n* medically stable\n* able to communicate\n\nExclusion Criteria:\n\n* on medication: beta-blocker\n* adverse skin reaction to biosensor adhesive\n* non-English speaking\n* pregnant women\n* prisoners'}, 'identificationModule': {'nctId': 'NCT04652895', 'briefTitle': 'Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Shirley Ryan AbilityLab'}, 'officialTitle': 'Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury', 'orgStudyIdInfo': {'id': 'STU00212891'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Moderate-to-severe traumatic brain injury inpatients', 'description': 'Moderate-to-severe traumatic brain injury inpatients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Shirley Ryan Ability Lab', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'David Ripley', 'investigatorAffiliation': 'Shirley Ryan AbilityLab'}}}}