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

NCT06638606 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 1740

Last updated 2025-01-10

No results posted yet for this study

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.

Conditions

  • Sleep Deprivation
  • Gut Microbiota
  • Optometry Examinations
  • Oral Microbiota
  • Depression
  • Anxiety

Interventions

BEHAVIORAL

Sleep improvement techniques

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

Sponsors & Collaborators

  • Reza Rastmanesh

    lead OTHER

Principal Investigators

  • Reza Rastmanesh Principal investigator, unaffilaited, PhD

  • Abolfazl Sadeghinejad, MD

  • Javid Azizi, MD

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-08
Primary Completion
2026-12-15
Completion
2026-12-28

Countries

  • Iran

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06638606 on ClinicalTrials.gov