Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-02 @ 2:46 AM
Study NCT ID:
NCT03125967
Status:
UNKNOWN
Last Update Posted:
2022-05-09
First Post:
2017-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daily Light Exposure for Sleep Disturbance, Fatigue, and Functional Outcomes in Acute Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2017-04-12', 'studyFirstSubmitQcDate': '2017-04-18', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Sleep Time', 'timeFrame': 'From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days', 'description': '24/7 recording of total amount of time asleep via wrist-worn actigraph'}, {'measure': 'Sleep Efficiency', 'timeFrame': 'From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days', 'description': 'Recording of the proportion of time asleep relative to time in bed via wrist-worn actigraph'}, {'measure': 'Sleep Fragmentation Index', 'timeFrame': 'From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days', 'description': 'Recording of restlessness during a sleep period via wrist-worn actigraph'}, {'measure': 'Frequency of Daytime Naps', 'timeFrame': 'From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days', 'description': 'Recording of number of naps during daytime via wrist-worn actigraph'}], 'secondaryOutcomes': [{'measure': 'Karolinska Sleepiness Scale', 'timeFrame': 'Baseline and every 3 days plus at study completion, at least 10 days after consent', 'description': 'Patient-report measure of daytime sleepiness'}, {'measure': 'Wits Pictorial Sleepiness Scale', 'timeFrame': 'Baseline and every 3 days plus at study completion, at least 10 days after consent', 'description': 'Patient-report measure of daytime sleepiness'}, {'measure': 'Fatigue Visual Analog Scale', 'timeFrame': 'Baseline and every 3 days plus at study completion, at least 10 days after consent', 'description': 'Patient-report measure of global fatigue'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Traumatic Brain Injury', 'Non-traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '39510247', 'type': 'DERIVED', 'citation': "Weeks DL, Crooks E, O'Brien KE, Sprint G, Carter GT, Honn KA. A parallel-group randomized controlled trial of blue light versus red light for improving sleep, fatigue, and cognition following stroke: Pilot results and recommendations for further study. Contemp Clin Trials. 2024 Dec;147:107736. doi: 10.1016/j.cct.2024.107736. Epub 2024 Nov 6."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of daily morning exposure to colored light in patients receiving acute inpatient rehabilitation services for stroke, traumatic brain injury, or non-traumatic brain injury with sleep disturbances such as poor nighttime sleep and/or excessive daytime sleepiness.In a two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments, we are comparing the effects of daily morning exposure to either blue light or red light on objective sleep quality, subjective sleep quality, functional rehabilitation outcomes, cognitive symptoms, fatigue, and neurological symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Inpatient admission to St. Luke's Rehabilitation Institute for stroke, traumatic brain injury, or non-traumatic brain injury\n2. Male or female, 18 to 85 years of age (to match limits of assessment instruments)\n3. Able to provide written informed consent or have a legally authorized representative that can provide written informed consent\n4. Stable neurologic status, as determined from subject's medical records and the study physician's opinion based on no new or changing symptoms\n5. Normal vision or corrected to normal vision (if glasses or contacts are tinted, willing to remove during light exposure)\n6. Normal hearing or corrected to normal hearing\n7. Willing to complete baseline evaluations prior to inclusion in the study to include: sleepiness inventories, neuropsychological testing, self-report fatigue assessment\n\nExclusion Criteria:\n\n1. History of epileptic or other seizure disorder\n2. Cataract surgery in the past 12 months\n3. Significant visual impairment affecting light reaching the retina/performance of the retina: cataracts, macular degeneration, diabetic retinopathy, congenital blindness, total blindness, glaucoma, or retinal detachment\n4. Endorsement of suicidal ideation on the PHQ-9 depression screen (standard of care admission assessment at St. Luke's)\n5. Pre-injury diagnosis of a sleep disorder, including: sleep apnea, insomnia, narcolepsy or periodic limb movement syndrome\n6. Neurological disorders other than those attributed to the primary diagnosis, including multiple sclerosis, Parkinson's disease, Huntington's disease, Alzheimer's disease or other dementias, amyotrophic lateral sclerosis)\n7. Bipolar diagnosis\n8. Females who are pregnant as determined from subject's medical records or who are breastfeeding\n9. In active withdrawal from alcohol or street drugs\n10. Unwillingness to refrain from wearing tinted glasses or contact lenses during light exposure"}, 'identificationModule': {'nctId': 'NCT03125967', 'briefTitle': 'Daily Light Exposure for Sleep Disturbance, Fatigue, and Functional Outcomes in Acute Brain Injury', 'organization': {'class': 'OTHER', 'fullName': "St. Luke's Rehabilitation Institute"}, 'officialTitle': 'Effects of Colored Light Exposure on Sleep Disturbance, Fatigue, and Functional Outcomes Following Acute Brain Injury', 'orgStudyIdInfo': {'id': 'StLukesRI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Blue Light', 'description': 'Blue light exposure (Philips GoLite Blu HF3429/60) administered daily for 25 minutes between 8:00AM and 9:00AM', 'interventionNames': ['Other: Philips GoLite Blu HF3429/60']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Red Light', 'description': 'Red light exposure (Philips LivingColor Aura 70998/60/48) administered daily for 25 minutes between 8:00AM and 9:00AM', 'interventionNames': ['Other: Philips LivingColor Aura 70998/60/48']}], 'interventions': [{'name': 'Philips GoLite Blu HF3429/60', 'type': 'OTHER', 'description': 'Exposure to daily morning colored light in the 440-485 nm wavelength range', 'armGroupLabels': ['Blue Light']}, {'name': 'Philips LivingColor Aura 70998/60/48', 'type': 'OTHER', 'description': 'Exposure to daily morning colored light in the 625-740 nm wavelength range', 'armGroupLabels': ['Red Light']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Douglas L. Weeks, PhD', 'role': 'CONTACT', 'email': 'WeeksDL@st-lukes.org', 'phone': '509-939-1316'}, {'name': 'Douglas L. Weeks, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Luke's Rehabilitation Institute", 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'centralContacts': [{'name': 'Douglas L Weeks, PhD', 'role': 'CONTACT', 'email': 'weeksdl@st-lukes.org', 'phone': '509-473-6000'}], 'overallOfficials': [{'name': 'Douglas L Weeks, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Luke's Rehabilitation Institute"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Luke's Rehabilitation Institute", 'class': 'OTHER'}, 'collaborators': [{'name': 'Washington State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research', 'investigatorFullName': 'Douglas L. Weeks', 'investigatorAffiliation': "St. Luke's Rehabilitation Institute"}}}}