Sleep DeprivationNCT06638606
Microbiota Profiles in Newly Married Couples: Potential Effects on Vision, Sleep and Psychometric Parameters
An observational study of Sleep Deprivation and Gut Microbiota, run by Reza Rastmanesh at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Gut Microbiota, Optometry Examinations
- What is being tested?
- Sleep improvement techniques
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,740 participants
- Where
- 1 siteIran
- Study dates
- 8 Jan 2024to 14 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Sleep disorder (insomnia and hypersomnia)
- Depressive/anxiety states
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The metabolic activity, diversity and composition of the gut microbiota vary significantly between healthy individuals and insomniacs, and also between hypersomniacs and healthy people. While Clostridiales and Bacteroides are regarded to be the two most important biomarkers for differentiating between healthy people and insomniacs, a recent study demonstrated that an enhanced relative abundance of five genera including Lachnospiraceae UCG010, Hungatella, Collinsella, Gordonibacter and Blautia may be correlated with a diminished risk of some types of hypersomnia (narcolepsy type one). Contrarily, an enhanced relative abundance of class Betaproteobacteria, genus Ruminiclostridium and genus Alloprevotella may potentially increase the risk of narcolepsy type one.
Furthermore, recent studies demonstrated that there were no significant differences in alpha and beta diversity between the three groups nonmyopes (NM), progressive myopes (progressive myopes ) and stable myopes (SM). Nothwithstanding, the distributions of Dorea, Roseburia,, Faecalibacterium, Coprococcus, Bacteroides, Bifidobacterium, Megamonas, and Blautia were significantly higher in the myopes (SM and PM combined) when compared with emmetropes. The myopes showed significantly higher abundance of bacteria that are linked to the regulation of dopaminergic signalling, such as Bacteroides, Ruminococcus, Clostridium, Bifidobacterium. Participants with stable myopia were found to have a significantly higher proportion of Prevotella copri than those with progressive myopia. Bifidobacterium adolescentis, a gamma-aminobutyric acid (GABA)-producing bacterium, was significantly higher in all myopes than in NM and, in the comparison between SM and PM, it is significantly higher in SM. B. uniformis and B. fragilis, both GABA-producing Bacteroides, were present in relatively high abundance in all myopes and in SM compared with PM, respectively.
Some researches have detected substantial bacterial strain sharing across people with distinct intra-population, mother-to-infant and intra-household transmission patterns. There was considerable strain sharing among cohabiting people, with 32% and 12% median strain-sharing rates for the time since cohabitation and gut and oral microbiomes affected strain sharing more than genetics or age did.
Salivary samples were collected from all participant. Couples were instructed not to consume any food or drink, except water, for at least 30 min prior to sample collection. Saliva cortisol was then measured by LC-MS/MS as described before.
The validated Persian version Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), and Pittsburgh Sleep Quality Index (PSQI) will be employed to measure depression, anxiety, and sleep quality, respectively.
Insomnia in this study is defined as coexistence of both daytime dysfunction and difficulty resuming sleep. Hypersomnia is defined by a bed-rest total sleep time ≥19 hours during the 32-hour recording. SPSS software will be used to analyze the data.
Based on these premises, below hypotheses are proposed:
- Person-to-person bacterial transmission can change the sleep pattern in newly married couples through gut microbiota
- Person-to-person bacterial transmission can alter vision status in newly married couples through ocular microbiota
- Person-to-person bacterial transmission can alter depression and anxiety status in newly married couples through ocular microbiota
- Conditions
- Sleep Deprivation, Gut Microbiota, Optometry Examinations, Oral Microbiota, Depression, Anxiety
- Being tested
- Sleep improvement techniques
- Keywords
- Depression, Anxiety, Oral microbiota, Saliva cortisol
- Medical subject headings
- Sleep Deprivation, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep improvement techniquesBehavioural
Insomniac and hypersomniac individuals are given behavioral counselling to improve sleep.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sleep improvement techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Pattern
Sleep quality and quantity will be evaluated using Pittsburgh Sleep Quality Inventory.
Measured: 3 months later, sleep quality and quantity will be measured with Pittsburgh Sleep Quality Inventory
Optometry examinations
Measured: 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
Measured: 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.
Measured: 6 months later, will be measured using Beck Anxiety Inventory
Secondary outcomes (1)
Dry eye symptom
Dry eye disease (DED) will be evaluated using Ocular Surface Disease Index questionnaire. DED is classified as mild (13-22 points), moderate (23-32 points), or severe (33-100 points).
Measured: at 3, 6 and 12 months will be measured using Ocular Surface Disease Index (OSDI) questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start8 Jan 2024
- Primary completion14 Nov 2024
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,740 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reza Rastmanesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reza Rastmanesh, Shahid Beheshti University of Medical Sciences
- Investigators
- Reza Rastmanesh Principal investigator, unaffilaited, PhD, Principal investigatorAbolfazl Sadeghinejad, MD, Study directorJavid Azizi, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638606
- Sponsor's protocol ID
- INSF: 98R026323-2024
- Other IDs
- INSF: 98R026323-2024, IT. 24001670
- Status last verified
- Jun 2026
- First submitted
- 9 Oct 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Oral, fecal and conjunctival samples will be collected from participants and will be stored according to the standard protocols until further processing. On Day 1 and Day 2, all couples will participate in a gut microbiota composition study. Optometry examinations will be completed for each participant Three months later, 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), and global sleep assessment questionnaire (GSAQ). Insomnia in this study is defined as coexistence of both daytime dysfunction and difficulty resuming sleep. Hypersomnia is defined by a bed-rest total sleep time ≥19 hours during the 32-hour recording. SPSS software will be used to analyze the data. For more detail, contact me: r.rastmanesh@gmail.com
Publications
Zhang J, Lu X, Cheng Z, Zou D, Shi W, Wang T. Alterations of conjunctival microbiota associated with orthokeratology lens wearing in myopic children. BMC Microbiol. 2023 Dec 13;23(1):397. doi: 10.1186/s12866-023-03042-1.
PubMed 38087200Omar WEW, Singh G, McBain AJ, Cruickshank F, Radhakrishnan H. Gut Microbiota Profiles in Myopes and Nonmyopes. Invest Ophthalmol Vis Sci. 2024 May 1;65(5):2. doi: 10.1167/iovs.65.5.2.
PubMed 38691091Wu Y, Fan H, Feng Y, Yang J, Cen X, Li W. Unveiling the gut microbiota and metabolite profiles in guinea pigs with form deprivation myopia through 16S rRNA gene sequencing and untargeted metabolomics. Heliyon. 2024 May 6;10(9):e30491. doi: 10.1016/j.heliyon.2024.e30491. eCollection 2024 May 15.
PubMed 38756593Zhang Y, Zhou X, Lu Y. Gut microbiota and derived metabolomic profiling in glaucoma with progressive neurodegeneration. Front Cell Infect Microbiol. 2022 Aug 12;12:968992. doi: 10.3389/fcimb.2022.968992. eCollection 2022.
PubMed 36034713Li H, Liu S, Zhang K, Zhu X, Dai J, Lu Y. Gut microbiome and plasma metabolome alterations in myopic mice. Front Microbiol. 2023 Dec 21;14:1251243. doi: 10.3389/fmicb.2023.1251243. eCollection 2023.
PubMed 38179454Sun Y, Xie Y, Li J, Hou X, Sha Y, Bai S, Yu H, Liu Y, Wang G. Study on the relationship between adolescent myopia and gut microbiota via 16S rRNA sequencing. Exp Eye Res. 2024 Oct;247:110067. doi: 10.1016/j.exer.2024.110067. Epub 2024 Sep 3.
PubMed 39233303Li H, Du Y, Cheng K, Chen Y, Wei L, Pei Y, Wang X, Wang L, Zhang Y, Hu X, Lu Y, Zhu X. Gut microbiota-derived indole-3-acetic acid suppresses high myopia progression by promoting type I collagen synthesis. Cell Discov. 2024 Aug 27;10(1):89. doi: 10.1038/s41421-024-00709-5.
PubMed 39187483Walters EM, Phillips AJ, Hamill K, Norton PJ, Drummond SP. Anxiety predicts dyadic sleep characteristics in couples experiencing insomnia but not in couples without sleep disorders. J Affect Disord. 2020 Aug 1;273:122-130. doi: 10.1016/j.jad.2020.04.031. Epub 2020 May 12.
PubMed 32421592Saini EK, Keiley MK, Fuller-Rowell TE, Duke AM, El-Sheikh M. Socioeconomic Status and Sleep among Couples. Behav Sleep Med. 2021 Mar-Apr;19(2):159-177. doi: 10.1080/15402002.2020.1721501. Epub 2020 Feb 2.
PubMed 32008377Gunn HE, Buysse DJ, Hasler BP, Begley A, Troxel WM. Sleep Concordance in Couples is Associated with Relationship Characteristics. Sleep. 2015 Jun 1;38(6):933-9. doi: 10.5665/sleep.4744.
PubMed 25581920Coutinho J, Pereira A, Oliveira-Silva P, Meier D, Lourenco V, Tschacher W. When our hearts beat together: Cardiac synchrony as an entry point to understand dyadic co-regulation in couples. Psychophysiology. 2021 Mar;58(3):e13739. doi: 10.1111/psyp.13739. Epub 2020 Dec 23.
PubMed 33355941Liu S, Rovine MJ, Klein LC, Almeida DM. Synchrony of diurnal cortisol pattern in couples. J Fam Psychol. 2013 Aug;27(4):579-88. doi: 10.1037/a0033735.
PubMed 23978320Evangelista E, Lopez R, Barateau L, Chenini S, Bosco A, Jaussent I, Dauvilliers Y. Alternative diagnostic criteria for idiopathic hypersomnia: A 32-hour protocol. Ann Neurol. 2018 Feb;83(2):235-247. doi: 10.1002/ana.25141. Epub 2018 Feb 9.
PubMed 29323727Itani O, Kaneita Y, Munezawa T, Mishima K, Jike M, Nakagome S, Tokiya M, Ohida T. Nationwide epidemiological study of insomnia in Japan. Sleep Med. 2016 Sep;25:130-138. doi: 10.1016/j.sleep.2016.05.013. Epub 2016 Aug 30.
PubMed 27823706Chehri A, Goldaste N, Ahmadi S, Khazaie H, Jalali A. Psychometric properties of insomnia severity index in Iranian adolescents. Sleep Sci. 2021 Apr-Jun;14(2):101-106. doi: 10.5935/1984-0063.20200045.
PubMed 34381573
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota Profiles in Newly Married Couples: Potential Effects on Vision, Sleep and Psychometric Parameters
- ClinicalTrials.gov ID
- NCT06638606
- Acronym / sponsor ID
- INSF: 98R026323-2024
- Conditions
- Sleep Deprivation, Gut Microbiota, Optometry Examinations, Oral Microbiota, Depression, Anxiety
- Keywords
- Depression, Anxiety, Oral microbiota, Saliva cortisol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,740 participants (actual)
- Lead sponsor
- Reza RastmaneshUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The metabolic activity, diversity and composition of the gut microbiota vary significantly between healthy individuals and insomniacs, and also between hypersomniacs and healthy people. While Clostridiales and Bacteroides are regarded to be the two most important biomarkers for differentiating between healthy people and insomniacs, a recent study demonstrated that an enhanced relative abundance of five genera including Lachnospiraceae UCG010, Hungatella, Collinsella, Gordonibacter and Blautia may be correlated with a diminished risk of some types of hypersomnia (narcolepsy type one). Contrarily, an enhanced relative abundance of class Betaproteobacteria, genus Ruminiclostridium and genus Alloprevotella may potentially increase the risk of narcolepsy type one.
Furthermore, recent studies demonstrated that there were no significant differences in alpha and beta diversity between the three groups nonmyopes (NM), progressive myopes (progressive myopes ) and stable myopes (SM). Nothwithstanding, the distributions of Dorea, Roseburia,, Faecalibacterium, Coprococcus, Bacteroides, Bifidobacterium, Megamonas, and Blautia were significantly higher in the myopes (SM and PM combined) when compared with emmetropes. The myopes showed significantly higher abundance of bacteria that are linked to the regulation of dopaminergic signalling, such as Bacteroides, Ruminococcus, Clostridium, Bifidobacterium. Participants with stable myopia were found to have a significantly higher proportion of Prevotella copri than those with progressive myopia. Bifidobacterium adolescentis, a gamma-aminobutyric acid (GABA)-producing bacterium, was significantly higher in all myopes than in NM and, in the comparison between SM and PM, it is significantly higher in SM. B. uniformis and B. fragilis, both GABA-producing Bacteroides, were present in relatively high abundance in all myopes and in SM compared with PM, respectively.
Some researches have detected substantial bacterial strain sharing across people with distinct intra-population, mother-to-infant and intra-household transmission patterns. There was considerable strain sharing among cohabiting people, with 32% and 12% median strain-sharing rates for the time since cohabitation and gut and oral microbiomes affected strain sharing more than genetics or age did.
Salivary samples were collected from all participant. Couples were instructed not to consume any food or drink, except water, for at least 30 min prior to sample collection. Saliva cortisol was then measured by LC-MS/MS as described before.
The validated Persian version Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), and Pittsburgh Sleep Quality Index (PSQI) will be employed to measure depression, anxiety, and sleep quality, respectively.
Insomnia in this study is defined as coexistence of both daytime dysfunction and difficulty resuming sleep. Hypersomnia is defined by a bed-rest total sleep time ≥19 hours during the 32-hour recording. SPSS software will be used to analyze the data.
Based on these premises, below hypotheses are proposed:
- Person-to-person bacterial transmission can change the sleep pattern in newly married couples through gut microbiota
- Person-to-person bacterial transmission can alter vision status in newly married couples through ocular microbiota
- Person-to-person bacterial transmission can alter depression and anxiety status in newly married couples through ocular microbiota
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A: Normal couples (have normal sleep pattern), B: Insomniac and C: hypersomniac couples | – | Behavioral: Sleep improvement techniquesGroup A: Couples with normal sleep pattern. Group B: One spouse suffers from insomnia. Group C: Once spouse suffers from hypersomnia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Sleep disorder (insomnia and hypersomnia)
- Depressive/anxiety states
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep improvement techniquesInsomniac and hypersomniac individuals are given behavioral counselling to improve sleep. | Behavioural | A: Normal couples (have normal sleep pattern), B: Insomniac and C: hypersomniac couples |
Primary outcome
Sleep Pattern
Time frame: 3 months later, sleep quality and quantity will be measured with Pittsburgh Sleep Quality Inventory
Sleep quality and quantity will be evaluated using Pittsburgh Sleep Quality Inventory.
Optometry examinations
Time frame: 3 months
Depression
Time frame: 6 months later, will be measured using Beck Anxiety Inventory-II.
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
Anxiety
Time frame: 6 months later, will be measured using Beck Anxiety Inventory
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.
1 secondary outcome
Dry eye symptom
Time frame: at 3, 6 and 12 months will be measured using Ocular Surface Disease Index (OSDI) questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 38087200Zhang J, Lu X, Cheng Z, Zou D, Shi W, Wang T. Alterations of conjunctival microbiota associated with orthokeratology lens wearing in myopic children. BMC Microbiol. 2023 Dec 13;23(1):397. doi: 10.1186/s12866-023-03042-1.
- Background: PubMed 38691091Omar WEW, Singh G, McBain AJ, Cruickshank F, Radhakrishnan H. Gut Microbiota Profiles in Myopes and Nonmyopes. Invest Ophthalmol Vis Sci. 2024 May 1;65(5):2. doi: 10.1167/iovs.65.5.2.
- Background: PubMed 38756593Wu Y, Fan H, Feng Y, Yang J, Cen X, Li W. Unveiling the gut microbiota and metabolite profiles in guinea pigs with form deprivation myopia through 16S rRNA gene sequencing and untargeted metabolomics. Heliyon. 2024 May 6;10(9):e30491. doi: 10.1016/j.heliyon.2024.e30491. eCollection 2024 May 15.
- Background: PubMed 36034713Zhang Y, Zhou X, Lu Y. Gut microbiota and derived metabolomic profiling in glaucoma with progressive neurodegeneration. Front Cell Infect Microbiol. 2022 Aug 12;12:968992. doi: 10.3389/fcimb.2022.968992. eCollection 2022.
- Background: PubMed 38179454Li H, Liu S, Zhang K, Zhu X, Dai J, Lu Y. Gut microbiome and plasma metabolome alterations in myopic mice. Front Microbiol. 2023 Dec 21;14:1251243. doi: 10.3389/fmicb.2023.1251243. eCollection 2023.
- Background: PubMed 39233303Sun Y, Xie Y, Li J, Hou X, Sha Y, Bai S, Yu H, Liu Y, Wang G. Study on the relationship between adolescent myopia and gut microbiota via 16S rRNA sequencing. Exp Eye Res. 2024 Oct;247:110067. doi: 10.1016/j.exer.2024.110067. Epub 2024 Sep 3.
- Background: PubMed 39187483Li H, Du Y, Cheng K, Chen Y, Wei L, Pei Y, Wang X, Wang L, Zhang Y, Hu X, Lu Y, Zhu X. Gut microbiota-derived indole-3-acetic acid suppresses high myopia progression by promoting type I collagen synthesis. Cell Discov. 2024 Aug 27;10(1):89. doi: 10.1038/s41421-024-00709-5.
- Background: PubMed 32421592Walters EM, Phillips AJ, Hamill K, Norton PJ, Drummond SP. Anxiety predicts dyadic sleep characteristics in couples experiencing insomnia but not in couples without sleep disorders. J Affect Disord. 2020 Aug 1;273:122-130. doi: 10.1016/j.jad.2020.04.031. Epub 2020 May 12.
- Background: PubMed 32008377Saini EK, Keiley MK, Fuller-Rowell TE, Duke AM, El-Sheikh M. Socioeconomic Status and Sleep among Couples. Behav Sleep Med. 2021 Mar-Apr;19(2):159-177. doi: 10.1080/15402002.2020.1721501. Epub 2020 Feb 2.
- Background: PubMed 25581920Gunn HE, Buysse DJ, Hasler BP, Begley A, Troxel WM. Sleep Concordance in Couples is Associated with Relationship Characteristics. Sleep. 2015 Jun 1;38(6):933-9. doi: 10.5665/sleep.4744.
- Background: PubMed 33355941Coutinho J, Pereira A, Oliveira-Silva P, Meier D, Lourenco V, Tschacher W. When our hearts beat together: Cardiac synchrony as an entry point to understand dyadic co-regulation in couples. Psychophysiology. 2021 Mar;58(3):e13739. doi: 10.1111/psyp.13739. Epub 2020 Dec 23.
- Background: PubMed 23978320Liu S, Rovine MJ, Klein LC, Almeida DM. Synchrony of diurnal cortisol pattern in couples. J Fam Psychol. 2013 Aug;27(4):579-88. doi: 10.1037/a0033735.
- Individual participant dataSharing planned: Yes. Oral, fecal and conjunctival samples will be collected from participants and will be stored according to the standard protocols until further processing. On Day 1 and Day 2, all couples will participate in a gut microbiota composition study. Optometry examinations will be completed for each participant Three months later, 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), and global sleep assessment questionnaire (GSAQ). Insomnia in this study is defined as coexistence of both daytime dysfunction and difficulty resuming sleep. Hypersomnia is defined by a bed-rest total sleep time ≥19 hours during the 32-hour recording. SPSS software will be used to analyze the data. For more detail, contact me: r.rastmanesh@gmail.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reza Rastmanesh Principal investigator, unaffilaited, PhD principal investigator
Abolfazl Sadeghinejad, MD study director
Javid Azizi, MD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Deprivation and Gut Microbiota, run by Reza Rastmanesh at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Pattern (time frame: 3 months later, sleep quality and quantity will be measured with Pittsburgh Sleep Quality Inventory). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06638606, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.