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

NCT06638606 | Enrolling By Invitation

• 2 other identifiers: it24412IT. 24001670
• Study Type: observational
• Target: 1,740
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Depression; Anxiety; Oral microbiota; Saliva cortisol

Outcome Measures

Primary Outcomes (4)

• Sleep Pattern

  Sleep quality and quantity will be evaluated using Pittsburgh Sleep Quality Inventory.

  3 months later, sleep quality and quantity will be measured with Pittsburgh Sleep Quality Inventory

• Optometry examinations

  3 months

• Depression

  The BDI-II is a commonly utilized 21-item self-report inventory designed for assessing depressive symptomatology, referring to the last two weeks. Higher scores demonstrate more severe depressive symptomatology. Depression in this study was defined as a BDI-II score ≥14

  6 months later, will be measured using Beck Anxiety Inventory-II.

• Anxiety

  BAI questionnaire has 21 items with scores ranging from 0-3 for each item, in which 0 indicates "not at all," 1 indicates "mildly, but it did not bother me much," 2 indicates "moderately, it was not pleasant at times," and 3 indicates "severely, it bothered me a lot" for all the items.

  6 months later, will be measured using Beck Anxiety Inventory

Secondary Outcomes (1)

• Dry eye symptom

  at 3, 6 and 12 months will be measured using Ocular Surface Disease Index (OSDI) questionnaire

Study Arms (1)

A: Normal couples (have normal sleep pattern), B: Insomniac and C: hypersomniac couples

Group A: Couples with normal sleep pattern. Group B: One spouse suffers from insomnia. Group C: Once spouse suffers from hypersomnia.

Behavioral: Sleep improvement techniques

Interventions

Sleep improvement techniques BEHAVIORAL

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

A: Normal couples (have normal sleep pattern), B: Insomniac and C: hypersomniac couples

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All volunteer participants who had been officially married during the past six months and are in a cohabiting relationship will be invited to participate in this study together with their official spouses.

You may qualify if:

• Sleep disorder (insomnia and hypersomnia)
• Depressive/anxiety states

You may not qualify if:

• Medicines known to affect gut/oral/ocular microbiota composition
• Pregnant/pregnancy
• Divorce during the study
• Antibiotics use in the past month
• Ongoing, active ocular infection, including conjunctivitis.
• Not having any prior history with Dry eye disease

Sponsors & Collaborators

• Reza Rastmanesh: lead

Study Sites (1)

Private sleep clinic

Tehran, 1961835555, Iran

Location

Related Publications (22)

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Biospecimen

Retention: SAMPLES WITH DNA

Oral, fecal and conjunctival samples will be collected from participants and will be stored (at - 20, and - 80◦C, respectively) until further processing.

MeSH Terms

Conditions

Sleep Deprivation; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Reza Rastmanesh Principal investigator, unaffilaited, PhD

  PRINCIPAL INVESTIGATOR

• Abolfazl Sadeghinejad, MD

  STUDY DIRECTOR

• Javid Azizi, MD

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

IR (1)