Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-31 @ 2:18 PM
Study NCT ID:
NCT03385993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-03
First Post:
2017-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Rehabilitation Environment Augmenting Medical System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2017-12-20', 'studyFirstSubmitQcDate': '2017-12-27', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of anxiety measured by Hospital Anxiety and Depression Scale (HADS) questionnaire', 'timeFrame': 'Immediately before and after each intervention Up to 7 days', 'description': "The assessment is used to gauge the subject's level of anxiety and depression 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)"}, {'measure': 'Blood Pressure -Systolic', 'timeFrame': 'Immediately before and after each intervention up to 7 days', 'description': 'Alterations to vital signs allow for Non-Verbal Pain assessments'}, {'measure': 'Heart Rate', 'timeFrame': 'Immediately before and after each intervention up to 7 days', 'description': 'Alterations to vital signs allow for Non-Verbal Pain assessments'}], 'secondaryOutcomes': [{'measure': 'Respiratory Rate', 'timeFrame': 'Entire ICU stay up to 7 days', 'description': 'Alterations to vital signs allow for Non-Verbal Pain assessments'}, {'measure': 'Patient pain perception', 'timeFrame': 'Immediately before and after each intervention up to 7 days', 'description': 'Defense and Veterans Pain Rating Scale (DVPRS) Likert Scale 0 - 10, with 10 = severe pain (as bad as it could be. nothing else matters)'}, {'measure': 'Amount of sedatives requested by subjects', 'timeFrame': 'Entire ICU stay up to 7 days', 'description': 'Richmond Agitation-Sedation Scale (RASS)- Patients with a RASS of -3 or less should have their sedation decreased or modified in order to achieve a RASS of -2 to 0. Patients with a RASS of 2 to 4 are not sedated enough and should be assessed for pain, anxiety, or delirium. The underlying etiology of the agitation should be investigated and appropriately treated to achieve a RASS of -2 to 0.'}, {'measure': 'Amount of sedatives subjects receive', 'timeFrame': 'Entire ICU stay up to 7 days', 'description': 'Richmond Agitation-Sedation Scale (RASS)- Patients with a RASS of -3 or less should have their sedation decreased or modified in order to achieve a RASS of -2 to 0. Patients with a RASS of 2 to 4 are not sedated enough and should be assessed for pain, anxiety, or delirium. The underlying etiology of the agitation should be investigated and appropriately treated to achieve a RASS of -2 to 0.'}, {'measure': "Subject's quality of sleep", 'timeFrame': 'Daily up to 14 days', 'description': 'Richards-Campbell Sleep Questionnaire (RCSQ) five-item, visual analogue scale was designed as an outcome measure for assessing the perception of sleep in critically ill patients. The scale evaluates perceptions of depth of sleep, sleep onset latency, number of awakenings, time spent awake, and overall sleep quality.'}, {'measure': 'DREAMS usability and acceptability questionnaire', 'timeFrame': 'After each intervention up to 14 days', 'description': 'A qualitative assessment of the usability and efficacy of the system Likert Scale 1-5, with 5 = strongly disagree.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Delirium Prevention', 'Virtual Reality', 'VR'], 'conditions': ['Delirium']}, 'descriptionModule': {'briefSummary': 'D.R.E.A.M.S. will assess an immersive digital reality-augmenting system in reducing the occurrence of cognitive, behavioral, and emotional consequences of critical illness and environmental exposures that are risk factors for the development of delirium.', 'detailedDescription': 'The purpose of Digital Rehabilitation Environment Augmenting Medical System (D.R.E.A.M.S.) is to research the feasibility and clinical potential of an immersive digital reality-augmenting system in reducing the occurrence of cognitive, behavioral, and emotional consequences of critical illness (e.g. pain, anxiety and insomnia) and environmental exposures (noise \\& light) that are risk factors for the development of delirium, a common and devastating complication in the intensive care unit (ICU).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients ≥ 18 years admitted to University of Florida (UF) Health Shands Hospital who do not have a positive Confusion Assessment Method (CAM) score, including ICU patients.\n\nExclusion Criteria: The study team will exclude patients if:\n\n* Their anticipated ICU stay is less than one day\n* Patient is intubated and cannot communicate.\n* Age: \\< 18 years\n* Patient with recent (within 6 months) neuro-vascular event, intra-cranial surgery, and/or acute neurological condition as primary ICU admission reason\n* Baseline cognitive impairment (e.g., advanced dementia)\n* Patients who are unable to wear or use the DREAMS equipment'}, 'identificationModule': {'nctId': 'NCT03385993', 'acronym': 'DREAMS', 'briefTitle': 'Digital Rehabilitation Environment Augmenting Medical System', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Digital Rehabilitation Environment Augmenting Medical System', 'orgStudyIdInfo': {'id': 'IRB201703107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mediation and Relaxation Intervention', 'description': 'Patients will undergo a technology based guided meditation and relaxation exercise through use of an application on a tablet or virtual reality headset.', 'interventionNames': ['Device: Technology based guided meditation and relaxation']}], 'interventions': [{'name': 'Technology based guided meditation and relaxation', 'type': 'DEVICE', 'description': 'Subjects will be guided through a mediation and relaxation exercise on a tablet or virtual reality headset for up to an hour each day.', 'armGroupLabels': ['Mediation and Relaxation Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Azra Bihorac, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}