Eye Mask on Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease

Not Applicable

Not yet recruiting

• Conditions: Dry Eye Disease
• Interventions: Device: Eye mask

• Registration Number: NCT06016166
• Lead Sponsor: Hamideh Sabbaghi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-24
• Last Update Submitted: 2023-08-24
• Study First Posted: 2023-08-29
• Last Update Posted: 2023-08-29
• Study Start: 2023-10-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Patients with dry eye disease according to the OSDI test

Exclusion Criteria

• Patients with eye disease except dry eye
• Patients using systemic and ophthalmic drugs
• Patients using sleeping and sedative pills

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Eye mask users	Eye mask	The eyes of the patients will be defined as the intervention

Primary Outcome Measures

Name	Time	Method
The effect of using eye mask on sleep quality between baseline and follow- ups of weeks 2 and 4 in patients with dry eye	between baseline and follow- ups of weeks 2 and 4	Sleep quality is measured by PSQI test based on the obtained score
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	between baseline and follow- ups of weeks 2 and 4	Tear film function is measured quantitatively and qualitatively by the Schirmer (based on millimeters) and TBUT ( based on seconds) test

Trial Locations

Locations (1)

Hamideh Sabbaghi; 🇮🇷 Tehran, Iran, Islamic Republic of