The Impact of Obstructive Sleep Apnoea in Women With Polycystic Ovary Syndrome.

NCT03065322 | Completed

• 2 other identifiers: MW181216213996
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Women with PCOS and OSA, compared to women with PCOS only, have more severe clinical and biochemical features of PCOS and impaired QoL. This is an observational cross-sectional study in a secondary care PCOS clinic in the WISDEM Centre, University Hospital Coventry. The primary aim of this study is to examine the relationship between OSA and impaired QoL in women with PCOS. Study secondary outcomes are to examine the relationship between OSA and the clinical and biochemical features in women with PCOS.

Conditions

Polycystic Ovary Syndrome; Obstructive Sleep Apnea

Keywords

PCOS; OSA

Outcome Measures

Primary Outcomes (1)

• Difference in scores on the World Health Organisation QoL questionnaire (WHOQOL-BREF) between women with PCOS and low risk of OSA compared to women with PCOS and OSA.

  Quality of life will be measured using the World Health Organisation QoL-BREF (WHOQOL-BREF) questionnaire.

  One day.

Secondary Outcomes (7)

• Difference in BMI between women with PCOS and low risk of OSA compared to women with PCOS and OSA.

  One day.

• Difference in the number of periods per year between women with PCOS and low risk of OSA compared to women with PCOS and OSA

  One day.

• Difference in scores on the Hospital Anxiety and Depression (HAD) scale between women with PCOS and low risk of OSA compared to women with PCOS and OSA.

  One day.

• Difference in the levels of HOMA-IR between women with PCOS and low risk of OSA compared to women with PCOS and OSA in women with PCOS.

  One day.

• Difference in scores on the PCOS health-related quality of life questionnaire (PCOSQ) between women with PCOS and low risk of OSA compared to women with PCOS and OSA.

  One day

Study Arms (1)

Women with PCOS

Women with confirmed diagnosis of PCOS, based on the Rotterdam Criteria. To assess risk of OSA: the risk of OSA will be assessed using the Berlin questionnaire and the Epworth Sleepiness Scale (ESS). Women with at high risk of OSA will have home-based sleep studies performed.

Other: To assess risk of OSA

Interventions

To assess risk of OSA OTHER

The risk of OSA will be assessed using the Berlin questionnaire and the Epworth Sleepiness Scale (ESS). Women with at high risk of OSA will have home-based sleep studies performed. Study participants will be divided based on the results of the Berlin and ESS questionnaires and sleep studies into two groups: 1) PCOS low risk OSA: women with normal ESS and normal Berlin questionnaire (no sleep studies performed), or women with normal sleep studies; and 2) PCOS OSA: women with OSA proven by sleep studies.

Women with PCOS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with PCOS will be recruited consecutively from the PCOS clinic at the WISDEM centre, University Hospital Coventry. In addition, patient information sheet (PIS) and a study invitation letter will be sent to women with PCOS who attended the PCOS clinic in the last 12 months.

You may qualify if:

• Women with PCOS, defined by the Rotterdam criteria as 2 out of 3:
• Age ≥ 18 years.
• Able to provide written consent.
• Able to adequately understand English.
• Patients with unknown diagnosis of OSA, or who were investigated in the past and either found not to have OSA, or found to have OSA and are not on CPAP therapy.

You may not qualify if:

• Pregnancy or breastfeeding women.
• Patients who are unable to give consent.
• Patients known to have OSA treated with CPAP.
• Anyone under the age of 18 years.
• Unable to adequately understand or speak English.

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead
• University of Warwick: collaborator

Study Sites (1)

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

Related Publications (1)

• Kahal H, Tahrani AA, Kyrou I, Dimitriadis GK, Kimani PK, Barber TM, Nicholls M, Ali A, Weickert MO, Randeva HS. The relationship between obstructive sleep apnoea and quality of life in women with polycystic ovary syndrome: a cross-sectional study. Ther Adv Endocrinol Metab. 2020 Feb 21;11:2042018820906689. doi: 10.1177/2042018820906689. eCollection 2020.

  PMID: 32128106 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Martin O Weickert, MD, FRCP

  University Hospitals Coventry and Warwickshire NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: February 27, 2017
• Study Start: February 13, 2017
• Primary Completion: May 11, 2018
• Study Completion: January 1, 2019
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

GB (1)