At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Microbiota Profiles in Newly Married Couples: Potential Effects on Vision, Sleep and Psychometric Parameters
In Brief
An observational study evaluating Sleep improvement techniques for Sleep Deprivation and 5 related conditions. Completed, enrolled 1,740 participants across 1 site.
Detailed 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.
Study Details
Timeline
Arms & Interventions
Group A: Couples with normal sleep pattern. Group B: One spouse suffers from insomnia. Group C: Once spouse suffers from hypersomnia.
Interventions
Insomniac and hypersomniac individuals are given behavioral counselling to improve sleep.