Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT02829892
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
2016-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Environmental Light Therapy to Improve Sleep and Neuropsychiatric Symptoms in Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010789', 'term': 'Phototherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-08', 'studyFirstSubmitDate': '2016-07-08', 'studyFirstSubmitQcDate': '2016-07-08', 'lastUpdatePostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep duration between 10 p.m to 5 a.m', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Sleep duration by day', 'timeFrame': '14 days'}, {'measure': 'Number of awake between 10 p.m to 5 a.m', 'timeFrame': '14 days'}, {'measure': 'Anxiety by the COVI scale', 'timeFrame': '14 days'}, {'measure': 'Behavioral disorders by the NPI scale', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Polypathology and Autonomy Loss']}, 'descriptionModule': {'briefSummary': "Alzheimer's disease and related syndromes (AD) is a disease affecting memory but also the relationship with the environment and empower people. Patients with AD present in 90% of cases of behavioral disorders and of these behavioral disorders include agitation, apathy but also sleep disorders by circadian rhythm impairment.. No study has shown proven efficacy on the behavior of patients with AD. The main objective of the study was to assess the influence of environmental light nighttime sleep of residents.", 'detailedDescription': "Alzheimer's disease and related syndromes (AD) is a disease affecting memory but also the relationship with the environment and empower people. Patients with AD present in 90% of cases of behavioral disorders and of these behavioral disorders include agitation, apathy but also sleep disorders by circadian rhythm impairment. In 2014, the Cochrane published a systematic review of the literature over the last 20 years concerning the use of light therapy in patients with a AD. No study has shown proven efficacy on the behavior of patients with AD. The main objective of the study was to assess the influence of environmental light therapy (from 5 a.m to 10 p.m) on nighttime sleep of residents. Secondary objectives were the study of sleep time on the day, anxiety by the COVI scale and behavioral disorders by the NPI scale."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* EHPAD residents at Les Pastoureaux Valenton having moderate to severe MASA\n* More than 60 years\n* Presenting motor behavioral disorders and / or anxiety and / or restlessness and / or insomnia .\n* No underlying acute medical problems including no delirium\n\nExclusion Criteria:\n\n* Residents refusing to lend to experimentation\n* Resident who are not matching with the inclusion criteria\n* total acquired or congenital blindness\n* bedridden patient ( loss of physical autonomy)\n* Entry to the residence less than 15 days before the start of the experiment.'}, 'identificationModule': {'nctId': 'NCT02829892', 'acronym': 'SOLEIL SOMMEIL', 'briefTitle': 'Using Environmental Light Therapy to Improve Sleep and Neuropsychiatric Symptoms in Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Using Environmental Light Therapy to Improve Sleep and Neuropsychiatric Symptoms in Dementia', 'orgStudyIdInfo': {'id': '14-PP-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Light therapy', 'description': 'Innovative ambient lighting', 'interventionNames': ['Device: Light therapy']}], 'interventions': [{'name': 'Light therapy', 'type': 'DEVICE', 'description': '14-days exposure with an innovative ambient light', 'armGroupLabels': ['Light therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94460', 'city': 'Valenton', 'country': 'France', 'facility': 'EHPAD ORPEA Valenton', 'geoPoint': {'lat': 48.74527, 'lon': 2.46467}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}