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

• Sponsor: Hamideh Sabbaghi (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06016166
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Device: Eye mask	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: The Effects of Eye Mask on Increasing the Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eye mask users The eyes of the patients will be defined as the intervention	Device: Eye mask; The 3D eye mask with the ability to adjust for different faces and eliminate light
No Intervention: Non eye mask users The eyes of the patients will be defined as the controls

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamideh Sabbaghi	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

• Hamideh Sabbaghi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hamideh Sabbaghi, Principal Investigator, Shahid Beheshti University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT06016166
• Other Study ID Numbers: IR.SBMU.RETECH.REC.1402.099
• First Posted: Aug 29, 2023
• Last Update Posted: Aug 29, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases

Study Results

No Results Posted as of Aug 29, 2023