Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-29 @ 11:58 AM
Study NCT ID:
NCT05524961
Status:
RECRUITING
Last Update Posted:
2025-04-15
First Post:
2022-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The subjects will be explained that the study aims to test the efficacy of the different modalities of non-pharmacological treatments for depression including bright light therapy and the negative ion generator, without mentioning which one is the placebo. An independent outcome assessor will be blinded to the treatment allocation throughout the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized placebo- and active-controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 69}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2022-08-25', 'studyFirstSubmitQcDate': '2022-08-30', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of daytime sleepiness', 'timeFrame': 'at the end of 6-week treatment', 'description': 'Change in the score of Epworth Sleepiness Scale (ESS), ESS score ranges from 0-24, higher score indicates greater sleepiness'}], 'secondaryOutcomes': [{'measure': 'Change of depressive symptoms', 'timeFrame': 'at the end of 6-week treatment', 'description': 'Change in the score of Montgomery-Åsberg Depression Rating Scale (MADRS), MARDS ranges from 0-60, higher score indicates greater severity of depressive symptoms'}, {'measure': 'Change in fatigue symptoms', 'timeFrame': 'at the end of 6-week treatment', 'description': 'Change in the score of Faitgue Severity Scale (FSS), FSS consists of 9 items and each as rated on a scale from 1-7, higher score indicates greater severity of fatigue'}, {'measure': 'Change in quality of life', 'timeFrame': 'at the end of 6-week treatment', 'description': 'Change in score of Short-Form 12-item (SF-12) scale. SF-12 consists of two subscales - a mental component score (MCS-12) and a physical component score (PCS-12), a higher score indicates better quality of life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson disease', 'Light therapy', 'Daytime sleepiness', 'Non-motor symptom'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "This is a randomized placebo- and active-controlled trial for assessing the efficacy of bright light therapy for sleep and mood symptoms in patients with Parkinson's disease", 'detailedDescription': "The primary aim of this study is to compare the efficacy of timed-BLT (BLT group) in reducing excessive daytime sleepiness in patients with Parkinson's disease, when compared to a timed-inactivated negative ion generator (active-control group).\n\nThe secondary aims of the study are to examine the effect of timed-BLT on other non-motor symptoms, including depression, fatigue; and the quality of life.\n\nAdditional analyses will be carried out to examine the efficacy of the timed-placebo as compared to the random-time placebo (placebo group)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Idiopathic Parkinson's disease diagnosed by neurologist according to the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria\n2. Capable to give informed consent\n3. Maintained on stable dose of medications for Parkinson's disease/psychotropic drugs for at least four weeks prior to entry of the study\n4. Score 14 or more on the Epworth Sleepiness Scale\n\nExclusion Criteria:\n\n1. A current or past history of manic or hypomanic episode, schizophrenia, mental retardation, or substance use disorder. (Subjects with depression or anxiety disorders will not be excluded)\n2. Unstable medical or psychiatric condition\n3. Presence of substantial suicidal risk as judged by the clinician and/or screening instruments\n4. Presence of active psychotic symptoms that might impair the ability to consent or validity of the interview\n5. Cognitive impairment with score of 19 or below by the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA)\n6. Contraindication to bright light therapy: history of light induced migraine. Epilepsy, current use of photosensitizing medications, presence of eye disease, e.g. retinal disease, severe cataract, glaucoma and blindness\n7. Significant medical condition/ hearing impairment/ speech deficit lead to incapability in completing clinical interview\n8. Regular shift worker or trans-meridian flight in the past three months\n9. Enrolment in another clinical trial of an investigational medicinal product or device\n10. Subjects who are on exogenous melatonin\n11. Patients with deep brain stimulation (DBS) implant\n12. Patients with known sleep disorders, eg. untreated severe sleep apnea, restless leg syndrome"}, 'identificationModule': {'nctId': 'NCT05524961', 'briefTitle': "Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': "Randomized Placebo- and Active-controlled Trial for Assessing the Efficacy of Bright Light Therapy for Sleep and Mood Symptoms in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': '2021.676T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Timed-Bright light therapy (BLT group)', 'description': '10,000lux bright light', 'interventionNames': ['Device: Bright light therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Timed-inactivated negative ion generator (Active-control group)', 'description': 'Inactivated negative ion generator', 'interventionNames': ['Device: Inactivated negative ion generator']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Random-time inactivated negative ion generator (placebo group)', 'description': 'Inactivated negative ion generator', 'interventionNames': ['Device: Inactivated negative ion generator']}], 'interventions': [{'name': 'Bright light therapy', 'type': 'DEVICE', 'description': 'Regularly-timed exposure to 10,000lux bright light therapy for 60minutes a day for six weeks', 'armGroupLabels': ['Timed-Bright light therapy (BLT group)']}, {'name': 'Inactivated negative ion generator', 'type': 'DEVICE', 'description': 'Regularly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks', 'armGroupLabels': ['Timed-inactivated negative ion generator (Active-control group)']}, {'name': 'Inactivated negative ion generator', 'type': 'DEVICE', 'description': 'Randomly-timed exposure to an inactivated negative ion generator for 60minutes a day for six weeks', 'armGroupLabels': ['Random-time inactivated negative ion generator (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': 'Clinical Associate Professor', 'investigatorFullName': 'Joey WY Chan', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}