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

The Impact of Obstructive Sleep Apnoea in Women With Polycystic Ovary Syndrome: A Cross-sectional Study

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome; Obstructive Sleep Apnea
• Intervention / Treatment: Other: To assess risk of OSA

Detailed Description

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. PCOS is associated with multiple co-morbidities including obesity, insulin resistance, subfertility, impaired quality of life (QoL) and increased risk of type 2 diabetes. Obstructive sleep apnoea (OSA) is a common medical condition that is often undiagnosed, particularly in women. Obesity is a common risk factor for OSA and PCOS and OSA is associated with comorbidities similar to those observed in patients with PCOS such as insulin resistance, increased risk of type 2 diabetes, and impaired QoL. Hence it is not surprising that OSA and PCOS might co-exist.

However, the impact of OSA in women with PCOS remains unclear and understudied. It is plausible that OSA may contribute to the subfertility and impaired QoL observed in women with PCOS by increasing insulin resistance, activation of the sympathetic nervous system, disturbing the hypothalamic/pituitary/ovarian axis, and contributing to excessive daytime sleepiness and reduced mood.

38 women with PCOS will be recruited from the PCOS clinic, weight management clinic, reproductive endocrinology clinic and through posters displayed at University Hospital Coventry and an e-poster displayed at the hospital intranet. Women with increased risk of OSA, based on the Berlin questionnaire and the Epworth Sleepiness Scale (ESS), will have home-based sleep studies performed. They will also be referred to the Respiratory Physician, as part of routine NHS care.

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.

Clinical and biochemical features including reproductive history, depression and anxiety [using the Hospital Anxiety and Depression questionnaire (HAD)], and QoL [using the PCOS health-related quality of life questionnaire (PCOSQ) and the World Health Organisation QoL-BREF will be compared between the two groups.

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Coventry, West Midlands, United Kingdom, CV2 2DX
      • University Hospitals Coventry & Warwickshire NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• Women with PCOS, defined by the Rotterdam criteria as 2 out of 3:

  1. Oligo/anovulation 2. Clinical or biochemical evidence of hirsutism 3. Polycystic ovaries on ultrasound. And the exclusion of other disorders with similar presentation including: non-classic congenital adrenal hyperplasia, androgen secreting tumours, Cushing's syndrome; thyroid disorders and prolactinomas.

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in BMI between women with PCOS and low risk of OSA compared to women with PCOS and OSA.	BMI will be calculated as kg/m2	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	Participants will be asked to recall how many periods they had in the last 4 months.	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.	Participants will be asked to complete HAD questionnaire.	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.	Fasting plasma glucose and insulin will be measured to calculate HOMA-IR	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.	Quality of life will be measured using the PCOS health-related quality of life questionnaire (PCOSQ).	One day
Difference in modified Ferriman-Gallwey score between women with PCOS and low risk of OSA compared to women with PCOS and OSA.	Hirsutism will be measured using the modified Ferriman-Gallwey score.	One day.
Difference in the levels of testosterone between women with PCOS and low risk of OSA compared to women with PCOS and OSA in women with PCOS.	Testosterone will be measured in nmol/L	One day.

Collaborators and Investigators

• Sponsor: University Hospitals Coventry and Warwickshire NHS Trust
• Collaborators: University of Warwick
• Investigators: Principal Investigator: Martin O Weickert, MD, FRCP, University Hospitals Coventry and Warwickshire NHS Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Actual): May 11, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: OSA; PCOS
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Signs and Symptoms, Respiratory; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Polycystic Ovary Syndrome; Syndrome; Apnea
• Other Study ID Numbers: MW181216; 213996 (Other Identifier: IRAS)