Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
Study NCT ID:
NCT06310161
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-24
First Post:
2024-01-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Light Therapy in End Stage Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2024-01-02', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue Severity Scale', 'timeFrame': '4 weeks', 'description': "Measures how bad or severe a person's fatigue is. Score range from 9-63; higher scores indicate increased fatigue."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test light therapy in patients with end stage kidney disease who are receiving hemodialysis. The main aim is to determine if light therapy decreases fatigue severity. Participants will receive light therapy using special glasses for one hour during the dialysis sessions for four weeks of treatment.', 'detailedDescription': 'In a single site, 2-arm (Bright Light Therapy group; Dim Light Group), parallel, randomized controlled trial we will enroll 60 subjects (n=30 per group) to assess the effects of Bright Light Therapy compared to Dim Light Therapy in subjects with end stage kidney disease who are receiving hemodialysis to treat fatigue.\n\n* To compare the effects of bright light therapy to dim light therapy on fatigue severity.\n* To explore the effects of bright light therapy to dim light therapy on salivary cortisol.\n* To compare the effects of bright light therapy to dim light therapy on insomnia, depression and quality of life.\n* To test the effects on bright light therapy to dim light therapy on physical activity levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent prior to initiation of any study mandated procedure\n2. Male and female participants ≥ 18 years of age\n3. Diagnosis end stage kidney disease with hemodialysis 3 times/week for at least 1 month\n4. Fatigue Severity Scale (FSS) \\> 9 at enrollment\n5. Home refrigerator for salivary cortisol storage\n\nExclusion Criteria\n\n1. Eye disorders: cataracts, glaucoma, retinal disorders (e.g. macular degeneration)\n2. Participants with photosensitivity (e.g. epilepsy)\n3. Hospitalized or acutely ill'}, 'identificationModule': {'nctId': 'NCT06310161', 'briefTitle': 'Light Therapy in End Stage Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Bright Light Therapy to Treat Fatigue in End Stage Kidney Disease', 'orgStudyIdInfo': {'id': '855161'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bright Light', 'description': 'Light therapy will be delivered by the Re-Timer glasses for 60 minutes during dialysis sessions.', 'interventionNames': ['Device: Bright light']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dim Light', 'description': 'Dim light therapy will be delivered by the Re-Timer glasses for 60 minutes during dialysis sessions.', 'interventionNames': ['Device: Dim Light']}], 'interventions': [{'name': 'Bright light', 'type': 'DEVICE', 'otherNames': ['Re-Timer'], 'description': 'Bright light treatment will consist of using the Re-timer device 3 times per week during dialysis sessions for 4 weeks. The Re-timer is worn like a pair of glasses and contains light emitting diodes mounted on the lower portion of the frame. The Re-timer emits blue-green 500 nm light with an intensity of \\~500 lux lm/m2. Participants will be instructed to use the device for 60 minutes at the beginning of each dialysis session.', 'armGroupLabels': ['Bright Light']}, {'name': 'Dim Light', 'type': 'DEVICE', 'otherNames': ['Re-Timer'], 'description': 'Dim light treatment will use non-light emitting glasses that look identical to Re-Timer for 4 weeks at each dialysis session following baseline assessments. Participants will use the device for 60 minutes at the beginning of their dialysis session.', 'armGroupLabels': ['Dim Light']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lea Ann Matura, PhD', 'role': 'CONTACT', 'email': 'matura@nursing.upenn.edu', 'phone': '215 746 8819'}], 'overallOfficials': [{'name': 'Lea Ann Matura, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}