Sleep DisorderPMOSNCT07898423
Association Between Polycystic Ovary Syndrome and Sleep Quality: A Questionnaire-Based Study
An observational study of Sleep Disorder and Polycystic Ovarian Syndrome (PCOS), run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional study enrolled 310 women with PCOS (Rotterdam criteria) at a tertiary referral center between September 2025 and January 2026. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI); a global score >5 defined poor sleep quality. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Sleep Disorder, Polycystic Ovarian Syndrome (PCOS)
- How many people
- 290 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2025to 5 May 2026
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women aged 18 to 45 years with polycystic ovary syndrome diagnosed according to the Rotterdam criteria who attended the gynecology outpatient clinic of the University of Health Sciences Tepecik Training and Research Hospital, Izmir, Turkey, between September 2025 and January 2026 and agreed to participate.
Who may be able to join
- Women aged 18 to 45 years
- Diagnosis of polycystic ovary syndrome according to the Rotterdam criteria, after exclusion of other causes of hyperandrogenism and ovulatory dysfunction (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia and thyroid dysfunction)
- Voluntary participation with written informed consent
Who cannot join
- Previously diagnosed primary sleep disorder (e.g., obstructive sleep apnea, narcolepsy)
- Any previously diagnosed psychiatric disorder (including depression and anxiety disorders) or current psychiatric treatment
- History of severe systemic disease (e.g., chronic kidney failure, liver disease)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tepecik Traning and Research Hospital
Izmir, Bornova, 35100
About this study
This cross-sectional study enrolled 310 women with PCOS (Rotterdam criteria) at a tertiary referral center between September 2025 and January 2026. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI); a global score >5 defined poor sleep quality. Logistic regression and Spearman correlation analyses were performed to identify independent predictors.
- Conditions
- Sleep Disorder, Polycystic Ovarian Syndrome (PCOS)
- Keywords
- sleep disorder, polycystic ovarian syndrome
- Medical subject headings
- Sleep Wake Disorders, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pcos | pcos sleep disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Poor Sleep Quality (PSQI Global Score >5)
Sleep quality over the preceding month is assessed with the Turkish version of the Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire. Its 7 component scores (each 0-3) are summed into a global score ranging from 0 to 21, with higher scores indicating worse sleep quality. Participants with a global score >5 are classified as having poor sleep quality and those with a score of 5 or less as having good sleep quality. The outcome is reported as the percentage of participants with poor sleep quality.
Measured: At enrollment (single assessment; the PSQI covers the preceding 1 month)
Secondary outcomes (1)
PSQI Global Score
Global score of the Turkish version of the Pittsburgh Sleep Quality Index (sum of 7 component scores; range 0-21; higher scores indicate worse sleep quality), reported as a continuous variable.
Measured: At enrollment (single assessment; the PSQI covers the preceding 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start20 Sep 2025
- Primary completion10 Jan 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisorderStudies 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
- Prospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uğurcan Dağlı, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898423
- Sponsor's protocol ID
- 2025/ 08-10
- Acronym
- PMOS
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and confidentiality considerations.
Publications
Zhang J, Ye J, Tao X, Lu W, Chen X, Liu C. Sleep disturbances, sleep quality, and cardiovascular risk factors in women with polycystic ovary syndrome: Systematic review and meta-analysis. Front Endocrinol (Lausanne). 2022 Sep 13;13:971604. doi: 10.3389/fendo.2022.971604. eCollection 2022.
PubMed 36176474
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Polycystic Ovary Syndrome and Sleep Quality: A Questionnaire-Based Study
- ClinicalTrials.gov ID
- NCT07898423
- Acronym / sponsor ID
- PMOS / 2025/ 08-10
- Conditions
- Sleep Disorder, Polycystic Ovarian Syndrome (PCOS)
- Keywords
- sleep disorder, polycystic ovarian syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 27 Oct 2026 (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.
This cross-sectional study enrolled 310 women with PCOS (Rotterdam criteria) at a tertiary referral center between September 2025 and January 2026. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI); a global score >5 defined poor sleep quality. Logistic regression and Spearman correlation analyses were performed to identify independent predictors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pcos | – | –pcos sleep disorder |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women aged 18 to 45 years with polycystic ovary syndrome diagnosed according to the Rotterdam criteria who attended the gynecology outpatient clinic of the University of Health Sciences Tepecik Training and Research Hospital, Izmir, Turkey, between September 2025 and January 2026 and agreed to participate.
Key inclusion criteria (3 listed)
- Women aged 18 to 45 years
- Diagnosis of polycystic ovary syndrome according to the Rotterdam criteria, after exclusion of other causes of hyperandrogenism and ovulatory dysfunction (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia and thyroid dysfunction)
- Voluntary participation with written informed consent
Key exclusion criteria (3 listed)
- Previously diagnosed primary sleep disorder (e.g., obstructive sleep apnea, narcolepsy)
- Any previously diagnosed psychiatric disorder (including depression and anxiety disorders) or current psychiatric treatment
- History of severe systemic disease (e.g., chronic kidney failure, liver disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Participants With Poor Sleep Quality (PSQI Global Score >5)
Time frame: At enrollment (single assessment; the PSQI covers the preceding 1 month)
Sleep quality over the preceding month is assessed with the Turkish version of the Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire. Its 7 component scores (each 0-3) are summed into a global score ranging from 0 to 21, with higher scores indicating worse sleep quality. Participants with a global score >5 are classified as having poor sleep quality and those with a score of 5 or less as having good sleep quality. The outcome is reported as the percentage of participants with poor sleep quality.
1 secondary outcome
PSQI Global Score
Time frame: At enrollment (single assessment; the PSQI covers the preceding 1 month)
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 29 Oct 2026.
- Results publication: PubMed 36176474Zhang J, Ye J, Tao X, Lu W, Chen X, Liu C. Sleep disturbances, sleep quality, and cardiovascular risk factors in women with polycystic ovary syndrome: Systematic review and meta-analysis. Front Endocrinol (Lausanne). 2022 Sep 13;13:971604. doi: 10.3389/fendo.2022.971604. eCollection 2022.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and confidentiality considerations.
Related trials for Sleep Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Disorder and Polycystic Ovarian Syndrome (PCOS), run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 29 Oct 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 Turkey (Türkiye). 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?
Proportion of Participants With Poor Sleep Quality (PSQI Global Score >5) (time frame: At enrollment (single assessment; the PSQI covers the preceding 1 month)). 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 NCT07898423, which also lists 1 linked publication.
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 29 Oct 2026.