Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2026-03-02 @ 1:08 AM
Study NCT ID:
NCT02216318
Status:
COMPLETED
Last Update Posted:
2018-08-06
First Post:
2014-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Energy-efficient and Health Promoting Light for Elderly People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095743', 'term': 'Blue Light'}], 'ancestors': [{'id': 'D008027', 'term': 'Light'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D055620', 'term': 'Optical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-03', 'studyFirstSubmitDate': '2014-08-12', 'studyFirstSubmitQcDate': '2014-08-12', 'lastUpdatePostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'pupillometry', 'timeFrame': 'the last day of each light period', 'description': 'the pupillary response to blue and red light'}, {'measure': 'melatonin', 'timeFrame': 'the last day of each light period', 'description': 'timing of melatonin onset'}, {'measure': 'Questionnaire', 'timeFrame': '3 weeks', 'description': 'Questionnaire count'}], 'primaryOutcomes': [{'measure': 'Sleep length', 'timeFrame': '1 week', 'description': 'The mean of sleep length during the last week of each light period'}], 'secondaryOutcomes': [{'measure': 'actigraphy', 'timeFrame': '1 week', 'description': 'mean sleep efficiency during the last week in each light period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sleep', 'circadian', 'melatonine', 'pupil response'], 'conditions': ['Sleep']}, 'descriptionModule': {'briefSummary': 'to investigate the effect of two lightning conditions on sleep hypothesizing that sleep length is influenced by the color of light during daytime', 'detailedDescription': 'Lightning conditions seems to be important for the length and quality of sleep, as light have an influence on the production of the sleep hormone (melatonin) and the the circadian rhythm. Entrainment of the circadian rhythm to the surroundings is accomplished by light-sensitive retinal ganglion cells and these cells are sensitive to blue light.\n\nBased on previous research, blue light early in the day and abscence of blue light during evening is important for the entrainment.\n\nIn this study, lightning conditions in the home of healthy subjects are set to either blue enriched or red enriched from 8 a.m to 1. p.m. The lightning condition is based on a randomization protocol in a cross-over study for 3 weeks in each condition, separated by a one week pause.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 65 to 85 years\n\nExclusion Criteria:\n\n* Conditions which will interfere by the primary endpoint as evaluated by the medical doctor'}, 'identificationModule': {'nctId': 'NCT02216318', 'acronym': 'light-age', 'briefTitle': 'Energy-efficient and Health Promoting Light for Elderly People', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'A Study of Two Different Light Conditions for Healthy Subjects Above 65 Years', 'orgStudyIdInfo': {'id': 'H-3-2013-085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'red light', 'description': 'red light during the whole day', 'interventionNames': ['Other: blue light']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Blue light', 'description': 'Blue light during early day', 'interventionNames': ['Other: blue light']}], 'interventions': [{'name': 'blue light', 'type': 'OTHER', 'armGroupLabels': ['Blue light', 'red light']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Line Kessel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Glostrup University Hospital, Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Elforsk', 'class': 'UNKNOWN'}, {'name': 'Albertslund Kommune', 'class': 'UNKNOWN'}, {'name': 'Gate 21', 'class': 'UNKNOWN'}, {'name': 'DTU Fotonik', 'class': 'UNKNOWN'}, {'name': 'VISO systems', 'class': 'UNKNOWN'}, {'name': 'AF Lightning', 'class': 'UNKNOWN'}, {'name': 'Philips Healthcare', 'class': 'INDUSTRY'}, {'name': 'Statens Byggeforskningsinstitut', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Line Kessel', 'investigatorAffiliation': 'Glostrup University Hospital, Copenhagen'}}}}