ClinicalTrials.gg
CompletedNCT07898423PMOSUpdated Oct 29, 2026

Association Between Polycystic Ovary Syndrome and Sleep Quality: A Questionnaire-Based Study

An observational study in Sleep Disorder and Polycystic Ovarian Syndrome (PCOS), sponsored by Tepecik Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Tepecik Training and Research Hospital · Observational

Updated Oct 29, 2026Now CompletedStart date moved+3 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
290
Ages
18 Years to 45 Years
Sex
Female
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Study 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. Logistic regression and Spearman correlation analyses were performed to identify independent predictors.

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Conditions studied

  • Sleep Disorder
  • Polycystic Ovarian Syndrome (PCOS)

Keywords

  • sleep disorder
  • polycystic ovarian syndrome
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In context

Sleep Wake Disorders

747 studies on the registry are indexed under Sleep Wake Disorders; 182 are open to participants now.

This study's enrollment of 290 is above the median of 120 across 197 observational studies indexed under Sleep Wake Disorders.

Browse Sleep Wake Disorders studies →

Lead sponsor

Tepecik Training and Research Hospital is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
290 participants (actual)
Patient registry
No

Groups and cohorts

  • pcos

    pcos sleep disorder

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: At enrollment (single assessment; the PSQI covers the preceding 1 month)

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Study locations

1 site
  • Tepecik Traning and Research Hospital
    Izmir, Bornova 35100, Turkey (Türkiye)
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References and documents

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 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared due to ethical and confidentiality considerations.

09

Updates

2 registry updates since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Oct 29, 2026
Start date
Sep 11, 2025→Sep 20, 2025
Oct 29, 2026
Primary completion
May 5, 2026→Jan 10, 2026
Oct 29, 2026
Study completion
Nov 20, 2026→May 5, 2026 (actual)
Oct 29, 2026
Registered
First appeared on the registry
Oct 27, 2026
Show all 2 updates
  1. Oct 29, 2026
    Active, not recruiting→Completed
    Start date Sep 11, 2025→Sep 20, 2025
    Primary completion May 5, 2026→Jan 10, 2026
    Study completion Nov 20, 2026→May 5, 2026 (now actual)
  2. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07898423
Lead sponsor
Tepecik Training and Research Hospital
Responsible party
Uğurcan Dağlı (Medical Doctor, Tepecik Training and Research Hospital) — Principal investigator
First posted
Oct 27, 2026
Start date
Sep 20, 2025
Primary completion
Jan 10, 2026
Completion
May 5, 2026
Last update
Oct 29, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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