Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT05771558
Status:
COMPLETED
Last Update Posted:
2025-07-16
First Post:
2023-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of a Lighting Intervention on Sleep in Parkinson Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020447', 'term': 'Parasomnias'}], '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': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-23', 'size': 393084, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-07-11T14:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-11', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-03-14', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep duration using Actigraph', 'timeFrame': 'at Baseline for 7 days', 'description': 'Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.'}, {'measure': 'Sleep duration using Actigraph', 'timeFrame': 'at Week 8 for 7 days', 'description': 'Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.'}], 'secondaryOutcomes': [{'measure': 'Sleep efficiency using Actigraph', 'timeFrame': 'at Baseline for 7 days', 'description': 'Sleep efficiency will be calculated by the Actigraph software. Sleep efficiency refers to the percentage of time a person sleeps, in relation to the amount of time a spent in bed. The percentage is calculated by dividing actual sleep time by time in bed. A higher sleep efficiency would indicate an improvement.'}, {'measure': 'Sleep efficiency using Actigraph', 'timeFrame': 'at Week 8 for 7 days', 'description': 'Sleep efficiency will be calculated by the Actigraph software. Sleep efficiency refers to the percentage of time a person sleeps, in relation to the amount of time a spent in bed. The percentage is calculated by dividing actual sleep time by time in bed. A higher sleep efficiency would indicate an improvement.'}, {'measure': 'Urine melatonin levels', 'timeFrame': 'at Baseline', 'description': 'Melatonin levels will be assessed from overnight urine collection'}, {'measure': 'Urine melatonin levels', 'timeFrame': 'at Week 8', 'description': 'Melatonin levels will be assessed from overnight urine collection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease', 'Sleep Disturbance']}, 'descriptionModule': {'briefSummary': "50 participants with Parkinson's disease will be recruited to complete actigraphy studies to assess sleep disturbances. For this, participants will wear an Actigraph for seven days. Thirty of these participants with sleep disturbance will go on to receive a tailored lighting intervention (TLI) to assess the effect on sleep, fatigue, and circadian entrainment via urinary melatonin levels.", 'detailedDescription': "Participants will undergo one week of baseline data collection using the actigraph and light meter and one night of an overnight urine collection. At the completion of the baseline week, the lighting intervention will be installed in the participants' home. Participants will be exposed to the lighting intervention for 2 hours each morning after awakening for 8 weeks. During the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days and collect one overnight urine sample. Participants will complete questionnaires before and after the intervention to further assess its effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease and difficulties with sleep and/or cognition\n\nExclusion Criteria:\n\n* There are no exclusion criteria"}, 'identificationModule': {'nctId': 'NCT05771558', 'briefTitle': 'The Effect of a Lighting Intervention on Sleep in Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': "Non-motor Features of Parkinson's Disease", 'orgStudyIdInfo': {'id': 'STUDY-22-00991'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tailored Lighting Intervention (TLI)', 'description': 'The TLI will be performed for 2 hours each day over an 8-week period\n\nDuring the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days', 'interventionNames': ['Device: Tailored Lighting Intervention (TLI)', 'Device: Actigraph']}], 'interventions': [{'name': 'Tailored Lighting Intervention (TLI)', 'type': 'DEVICE', 'description': 'The lighting intervention will provide high circadian stimulation produced by light sources that provide moderate light levels of spectra that are tuned to the sensitivity of the circadian system.', 'armGroupLabels': ['Tailored Lighting Intervention (TLI)']}, {'name': 'Actigraph', 'type': 'DEVICE', 'description': 'An actigraph is a wrist worn devices that measures rest and activity.', 'armGroupLabels': ['Tailored Lighting Intervention (TLI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Beth Israel', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Rachel Saunders-Pullman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai Beth Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Aggregate results will be published and shared upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rachel Saunders-Pullman', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}