Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
Study NCT ID:
NCT03578003
Status:
RECRUITING
Last Update Posted:
2025-11-14
First Post:
2018-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Morning Bright Light to Improve Sleep Quality in Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], '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': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2018-06-13', 'studyFirstSubmitQcDate': '2018-06-22', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insomnia Severity Index (ISI)', 'timeFrame': 'Baseline; after 4 weeks of intervention; and 2 months after the end of intervention', 'description': 'Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep', 'Bright Light'], 'conditions': ['Brain Injuries, Traumatic', 'Post-traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '35421086', 'type': 'DERIVED', 'citation': 'Elliott JE, McBride AA, Balba NM, Thomas SV, Pattinson CL, Morasco BJ, Wilkerson A, Gill JM, Lim MM. Feasibility and preliminary efficacy for morning bright light therapy to improve sleep and plasma biomarkers in US Veterans with TBI. A prospective, open-label, single-arm trial. PLoS One. 2022 Apr 14;17(4):e0262955. doi: 10.1371/journal.pone.0262955. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'One of the principal complicating factors associated with traumatic brain injury (TBI) is sleep-wake disturbances (e.g., insomnia, excessive daytime sleepiness, and circadian rhythm sleep disorders). Morning bright light therapy (MBLT) has been shown to improve sleep quality in a variety of conditions, but little has been done investigating the utility of MBLT in improving sleep in Veterans with TBI. This proposal aims to determine the effect of MBLT on sleep quality in Veterans with TBI. Veterans with and without TBI will be recruited from the VA Portland Health Care System. Baseline questionnaires and 7 days of actigraphy will be collected prior to engaging in 60 minutes of MBLT daily for 4 weeks, during which actigraphy will also be collected continuously. Post-MBLT questionnaire data will be collected, and follow-up questionnaire data will be collected at 3 months post-MBLT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veterans\n\nExclusion Criteria:\n\n* History of bipolar disorder\n* History of macular degeneration\n* Non-English speaking\n* Decisionally impaired\n* Currently using a light box'}, 'identificationModule': {'nctId': 'NCT03578003', 'briefTitle': 'Morning Bright Light to Improve Sleep Quality in Veterans', 'organization': {'class': 'FED', 'fullName': 'Portland VA Medical Center'}, 'officialTitle': 'Morning Bright Light to Improve Sleep Quality in Veterans', 'orgStudyIdInfo': {'id': '4085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Morning Bright Light Therapy', 'description': 'Subjects who engage in morning bight light therapy', 'interventionNames': ['Other: Morning Bright Light Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Subjects who do not engage in morning bright light therapy'}], 'interventions': [{'name': 'Morning Bright Light Therapy', 'type': 'OTHER', 'description': '60 minutes of bright light therapy (10,000 lux) received within 90 minutes of waking', 'armGroupLabels': ['Morning Bright Light Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portand', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Miranda M Lim, MD, PhD', 'role': 'CONTACT', 'email': 'lmir@ohsu.edu', 'phone': '503-220-8262', 'phoneExt': '57404'}], 'facility': 'VA Portland Health Care System'}], 'centralContacts': [{'name': 'Miranda M Lim, MD, PhD', 'role': 'CONTACT', 'email': 'lmir@ohsu.edu', 'phone': '503-220-8262', 'phoneExt': '57404'}, {'name': 'Jonathan E Elliott, PhD', 'role': 'CONTACT', 'email': 'elliojon@ohsu.edu', 'phone': '503-220-8262', 'phoneExt': '58020'}], 'overallOfficials': [{'name': 'Miranda M Lim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Portland VA Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Information will be sent as soon as is practical and will be available as long as the PI is available.', 'ipdSharing': 'YES', 'description': 'All non-identifiable data will be made available to qualified researchers on request to the study PI.', 'accessCriteria': 'Legitimate research agenda, including but not limited to request to double-check presented or published results and novel analyses.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Portland VA Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'Oregon Health and Science University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Physician and Assistant Professor', 'investigatorFullName': 'Miranda M Lim', 'investigatorAffiliation': 'Portland VA Medical Center'}}}}