Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT05677932
Status:
UNKNOWN
Last Update Posted:
2023-03-09
First Post:
2023-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bright Light Therapy for Post-COVID-19 Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014467', 'term': 'Ultraviolet Therapy'}], 'ancestors': [{'id': 'D010789', 'term': 'Phototherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The subjects will be explained that the study aims to test the efficacy of two different modalities of light treatments for fatigue including white light and red light, without mentioning which one is the placebo.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized placebo-controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-07', 'studyFirstSubmitDate': '2023-01-06', 'studyFirstSubmitQcDate': '2023-01-09', 'lastUpdatePostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of fatigue symptoms', 'timeFrame': 'at 2 weeks (at the end of treatment)', 'description': 'Change in the score of the Brief Fatigue Inventory (BFI). BFI ranges from 0 to 90, higher scales indicates more severe fatigue'}], 'secondaryOutcomes': [{'measure': 'Change of insomnia symptoms', 'timeFrame': 'at 2 weeks (at the end of treatment)', 'description': 'The change in the score of Insomnia Severity Index (ISI), which ranges from 0-28, higher score indicates higher severity of insomnia'}, {'measure': 'Change of depressive symptoms', 'timeFrame': 'at 2 weeks (at the end of treatment)', 'description': 'The change in the score of Patient Health Questionnaire -9 item (PHQ-9), which ranges from 0-27, with higher score indicates greater severity of depressive symptoms'}, {'measure': 'Change of anxiety symptoms', 'timeFrame': 'at 2 weeks (at the end of treatment)', 'description': 'The change in the score of Generalized Anxiety Disorder 7-item (GAD-7), which ranges from 0-21, with higher score indicates greater severity of anxiety symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Long COVID', 'Fatigue'], 'conditions': ['Post COVID-19 Condition']}, 'descriptionModule': {'briefSummary': 'This is a randomized placebo-controlled trial to examine the efficacy of two-week bright light therapy for patients with post-COVID-19 fatigue.', 'detailedDescription': 'This randomized placebo-controlled trial aims to evaluate the efficacy of BLT in reducing fatigue symptoms after COVID-19 infection. The second aim of the study is to explore the effects of BLT on insomnia, depression and anxiety symptoms.\n\nMethod: Each eligible participant will be randomized to either i) bright light therapy (BLT) or ii) dim red light (placebo) treatment for 30-minutes daily at their habitual wake time for a total of two weeks. Participants will be evaluated at baseline, 2nd (end of treatment), and 4th week (post-treatment 2-week) for fatigue and other symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or above\n* Capable to give informed consent\n* COVID-19 infection confirmed by PCR test or a Rapid Antigen Test (RAT) with onset of at least three months\n* Reports new onset or exacerbation of fatigue after onset of COVID-19 and lasted for over two months\n* Scoring 7 or above for the item "worst level of fatigue during the last 24 hours" in the Brief Fatigue Inventory\n\nExclusion Criteria:\n\n* A current or past history of bipolar disorder, schizophrenia, neurodevelopmental disorder, organic mental disorder; intellectual disabilities or substance use disorder.\n* Presence of contraindications to bright light therapy: for example, history of light induced migraine/ epilepsy; current use of photosensitizing medications; presence of eye disease: e.g. retinal blindness, severe cataract, glaucoma.\n* Significant medical condition/ hearing impairment/ speech deficit leading to incapability of completing clinical interview.\n* Regular shift-workers\n* Trans-meridian flight in the past 3 months and during the study\n* Currently receiving any structured psychotherapy\n* Self-reported untreated sleep disorders (e.g. severe insomnia, obstructive sleep apnea, restless leg syndrome), psychiatric illness (e.g. depression), or medical conditions associated with fatigue (e.g. anemia, heart failure, autoimmune disorders)\n* Enrolment in another clinical trial of an investigational medicinal product or device.'}, 'identificationModule': {'nctId': 'NCT05677932', 'briefTitle': 'Bright Light Therapy for Post-COVID-19 Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Bright Light Therapy for Post-COVID-19 Fatigue', 'orgStudyIdInfo': {'id': '2022.359'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bright light therapy', 'description': '10,000lux bright light', 'interventionNames': ['Device: Bright light therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo group', 'description': '50 lux dim red light', 'interventionNames': ['Device: Dim red light therapy']}], 'interventions': [{'name': 'Bright light therapy', 'type': 'DEVICE', 'description': 'Exposure to bright light therapy for 30mins a day for two weeks', 'armGroupLabels': ['Bright light therapy']}, {'name': 'Dim red light therapy', 'type': 'DEVICE', 'description': 'Exposure to 50lux dim red light therapy for 30mins a day for two weeks', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Joey WY Chan, FHKAM(Psych)', 'role': 'CONTACT', 'email': 'joeywychan@cuhk.edu.hk', 'phone': '+862 39197647'}, {'name': 'Jessie Tsang', 'role': 'CONTACT', 'email': 'jessietsang@cuhk.edu.hk', 'phone': '+852 39197792'}], 'facility': 'The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Joey WY Chan', 'role': 'CONTACT', 'email': 'joeywychan@cuhk.edu.hk', 'phone': '+852 39197647'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor (Clinical)', 'investigatorFullName': 'Joey WY Chan', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}