Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:13 PM
Study NCT ID:
NCT07488195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Of Phototherapy In Patients With Dementia To Improve BPSD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010789', 'term': 'Phototherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of 5-day phototherapy protocol', 'timeFrame': 'Day 5', 'description': 'Feasibility will be defined as the percentage of eligible patients who choose to enroll in the study out of total patients approached.'}, {'measure': 'Acceptability of 5-day phototherapy protocol', 'timeFrame': 'Day 5', 'description': 'Accessibility will be defined as the percentage of study participants to complete at least one session per day of the 5-day protocol'}, {'measure': 'Tolerability of 5-day phototherapy protocol', 'timeFrame': 'Day 5', 'description': 'Tolerability will be defined as percentage of patients to rate phototherapy as \'very tolerable\' based on being asked "Considering all aspects of your experience, how would you rate the overall tolerability of the phototherapy?" The response options are: very tolerable, somewhat tolerable, neutral, somewhat intolerable, and very intolerable.'}], 'secondaryOutcomes': [{'measure': 'Sleep duration', 'timeFrame': 'Day 5', 'description': 'Sleep duration will be reported by nursing staff in hours.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Use of phototherapy in patients with complex dementia'], 'conditions': ['Dementia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to determine whether the use of phototherapy can help reduce behavioral and psychological symptoms, including agitation in people with dementia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients admitted on the inpatient Domitilla 3D or 4D unit.\n* Documented diagnosis of dementia or suspected major neurocognitive disorder.\n* Presence of BPSD symptoms either clinician documented in EHR or assessed through CMAI-O form\n* Have patient consent or have a LAR able to sign the consent on behalf of the patient.\n\nExclusion Criteria:\n\n* Macular degeneration, blindness, or photosensitivity\n* Patients that do not have capacity to consent and do not have a legally authorized representative to consent on their behalf\n* Recent eye surgery\n* Bipolar disorder\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07488195', 'briefTitle': 'A Study Of Phototherapy In Patients With Dementia To Improve BPSD', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Implementation Of Phototherapy In Patients With Dementia To Improve BPSD: A Pilot Study.', 'orgStudyIdInfo': {'id': '25-005038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phototherapy', 'description': 'Patients in the phototherapy arm will receive bright light therapy for 60 minutes, 3 times per day for 5 days.', 'interventionNames': ['Other: Phototherapy']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Patients in the standard of care group will not receive an intervention.'}], 'interventions': [{'name': 'Phototherapy', 'type': 'OTHER', 'description': 'Bright light therapy will be provided via the Verilux HappyLight. The unit will be placed on a mobile bedside table, at eye level, 60 cm from the patient. Patients will receive phototherapy in 60 minute sessions, 3 times daily for 5 days.', 'armGroupLabels': ['Phototherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'contacts': [{'name': 'Melanie Gentry, MD', 'role': 'CONTACT', 'phone': '507-284-2933'}, {'name': 'Donna Lawson', 'role': 'CONTACT', 'phone': '507-255-7975'}, {'name': 'Stephanie P. Chambers, APRN, CNS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Melanie Gentry, MD', 'role': 'CONTACT', 'email': 'gentry.melanie@mayo.edu', 'phone': '507-284-2933'}, {'name': 'Donna Lawson', 'role': 'CONTACT', 'email': 'lawson.donna@mayo.edu', 'phone': '507-255-7975'}], 'overallOfficials': [{'name': 'Stephanie P. Chambers, APRN, CNS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stephanie Chambers', 'investigatorAffiliation': 'Mayo Clinic'}}}}