Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-26 @ 10:31 AM
Study NCT ID:
NCT06016166
Status:
UNKNOWN
Last Update Posted:
2023-08-29
First Post:
2023-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eye Mask on Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2023-08-15', 'studyFirstSubmitQcDate': '2023-08-24', 'lastUpdatePostDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of using eye mask on tear layer functions between baseline and follow- ups of weeks 2 and 4 in patients with dry eye', 'timeFrame': 'between baseline and follow- ups of weeks 2 and 4', 'description': 'Tear film function is measured quantitatively and qualitatively by the Schirmer (based on millimeters) and TBUT ( based on seconds) test'}, {'measure': 'The effect of using eye mask on sleep quality between baseline and follow- ups of weeks 2 and 4 in patients with dry eye', 'timeFrame': 'between baseline and follow- ups of weeks 2 and 4', 'description': 'Sleep quality is measured by PSQI test based on the obtained score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial (RCT) was aimed to determine the effects of eye masking on sleep quality and tear layer function in patients with dry eye disease. In this regard, a total of 34 patients with dry eye disease aged between 20 to 35 years old will be participated. They will be randomly divided into case and control (n=17) groups. Patients in the case group will be instructed to wear the eye mask as long as two weeks and the controls will be recommended to not wear it at the same time. Afterwards, the eye mask application will be cross- over for the next 2 hours between the two groups. Tear layer will be investigated in baseline and repeated in both follow- ups of weeks 2 and 4, either quantitatively and qualitatively, by using Schirmer and TBUT tests. Furthermore, the sleep quality will be checked by the PSQI test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with dry eye disease according to the OSDI test\n\nExclusion Criteria:\n\n* Patients with eye disease except dry eye\n* Patients using systemic and ophthalmic drugs\n* Patients using sleeping and sedative pills'}, 'identificationModule': {'nctId': 'NCT06016166', 'briefTitle': 'Eye Mask on Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'The Effects of Eye Mask on Increasing the Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease', 'orgStudyIdInfo': {'id': 'IR.SBMU.RETECH.REC.1402.099'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eye mask users', 'description': 'The eyes of the patients will be defined as the intervention', 'interventionNames': ['Device: Eye mask']}, {'type': 'NO_INTERVENTION', 'label': 'Non eye mask users', 'description': 'The eyes of the patients will be defined as the controls'}], 'interventions': [{'name': 'Eye mask', 'type': 'DEVICE', 'description': 'The 3D eye mask with the ability to adjust for different faces and eliminate light', 'armGroupLabels': ['Eye mask users']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'contacts': [{'name': 'Hamideh Sabbaghi, PhD', 'role': 'CONTACT', 'email': 'sabbaghi.opt@gmail.com', 'phone': '989120285930'}], 'facility': 'Hamideh Sabbaghi', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Hamideh Sabbaghi, PhD', 'role': 'CONTACT', 'email': 'sabbaghi.opt@gmail.com', 'phone': '989120285930'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamideh Sabbaghi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hamideh Sabbaghi', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}