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ENROLLING BY INVITATION
NCT06638606

Microbiota Profiles in Newly Married Couples: Potential Effects on Vision, Sleep and Psychometric Parameters

Sponsor: Reza Rastmanesh

View on ClinicalTrials.gov

Summary

Oral, fecal and conjunctival samples will be collected from participants and will be stored (at - 20 and - 80 ◦C) until further processing. On Day 1 and Day 2, all couples will participate in an oral, conjunctival and gut microbiota composition study. Optometry examinations will be completed for each participant Three and Six months later, oral, conjunctival and gut microbiota composition will be analyzed again with the same protocol. The participants will complete a validated Persian version of Pittsburgh Sleep Quality Inventory (PSQI), Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI), global sleep assessment questionnaire (GSAQ) and Ocular Surface Disease Index. Consecutive couples will undergo a standard ophthalmology exam and specific assessments for dry eye, including non-anesthetic Schirmer's test and fluorescein tear break-up time on Day 1 and Day 90.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

1740

Start Date

2024-10-08

Completion Date

2026-12-28

Last Updated

2025-01-10

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Sleep improvement techniques

Insomniac and hypersomniac individuals are given behavioral counselling to improve sleep.

Locations (1)

Private sleep clinic

Tehran, Iran