Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 1:37 PM
Study NCT ID:
NCT02909192
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-05
First Post:
2016-09-15
Is NOT Gene Therapy:
False
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-04', 'studyFirstSubmitDate': '2016-09-15', 'studyFirstSubmitQcDate': '2016-09-20', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Parkinson's Disease Sleep Scale (PDSS-2) score to measure sleep quality", 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Epworth Sleepiness Scale (ESS) score to measure daytime sleepiness', 'timeFrame': '8 weeks'}, {'measure': "Non-Motor Symptoms Assessment Scale for Parkinson's Disease (NMSS) score to measure the severity and frequency of non-motor symptoms", 'timeFrame': '8 weeks'}, {'measure': 'Plasma melatonin levels collected through blood samples to measure melatonin amplitude and circadian regulation', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'keywords': ["Parkinson's Disease", 'Excessive Daytime Sleepiness', 'Circadian Rhythms', 'Light Therapy'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "Disruption of sleep and alertness is one of the most disabling non-motor symptoms of Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not well understood, and treatment options remain limited. The proposed research will examine markers of the circadian system, sleepiness and sleep quality in PD patients. Further, the project will examine effects of bright light exposure on circadin function, sleep and alertness in PD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria\n2. PD Hoehn and Yahr stage 2-4\n3. Pittsburgh Sleep Quality Index (PSQI) score ≥ 5\n4. Treatment with levodopa and/or dopamine agonist; adjunctive PD medications will be allowed\n5. Stable dose of PD medications for at least 4 weeks prior to the study screening.\n\nExclusion criteria:\n\n1. Atypical or secondary forms of parkinsonism\n2. Co-existent significant sleep apnea (as assessed by polysomnography- derived apnea/hypopnea index ≥15 events/hr of sleep)\n3. Co-existent restless legs syndrome (RLS), as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria for RLS\n4. Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of ≤ 26\n5. Presence of depression defined as the Beck Depression Inventory (BDI) score \\>14\n6. Untreated hallucinations or psychosis (drug-induced or spontaneous)\n7. Use of hypno-sedative drugs for sleep or stimulants; participants will be allowed to taper these drugs and will become eligible 4 weeks after the taper is completed\n8. Use of Selective Serotonin Reuptake Inhibitors (SSRIs) / Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) antidepressants, unless the participant has been on a stable dose for at least 3 months prior to the screening\n9. Use of medications known to affect melatonin secretion, such as lithium, alpha- and beta-adrenergic antagonists\n10. Shift work, currently or within the prior 3 months\n11. Travel through ≥ 2 time zones within 60 days prior to study screening\n12. Hematocrit \\<32 mm3\n13. Pre-existing glaucoma/retinal disease contraindicated for light therapy (LT)\n14. Dense cataracts\n15. Use of medications known to photosensitize retinal tissue (phenothiazines, chloroquine, amiodarone, St. John's Wort)\n16. Unstable/serious medical illness.\n17. Pregnancy"}, 'identificationModule': {'nctId': 'NCT02909192', 'briefTitle': "Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': "Bright Light Modulation of Non-motor Symptoms in Parkinson's Disease", 'orgStudyIdInfo': {'id': '2016P001775'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bright light therapy', 'description': 'Participants will be treated twice daily with bright light therapy.', 'interventionNames': ['Device: Light Therapy Device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dim-Red light therapy', 'description': 'Participants will be treated twice daily with dim-red light therapy.', 'interventionNames': ['Device: Light Therapy Device']}], 'interventions': [{'name': 'Light Therapy Device', 'type': 'DEVICE', 'armGroupLabels': ['Bright light therapy', 'Dim-Red light therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Aleksandar Videnovic, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Neurologist', 'investigatorFullName': 'Aleksandar Videnovic, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}