PCOS OSA
Research type
Research Study
Full title
The impact of Obstructive Sleep Apnoea in women with Polycystic Ovary Syndrome: A Cross-Sectional Study.
IRAS ID
213996
Contact name
Martin / MOW Weickert
Contact email
Sponsor organisation
University Hospitals Coventry and Warwickshire NHS Trust
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Background: Polycystic ovary syndrome (PCOS) and Obstructive Sleep Apnoea (OSA) are two common medical conditions that are associated with obesity, insulin resistance, increased risk of type 2 diabetes and impaired quality of life. OSA is often undiagnosed, particularly in women. A few studies have suggested that OSA is common in women with PCOS. However, the impact of OSA in women with PCOS remains unclear and understudied.
Hypothesis: Women with PCOS and OSA, compared to women with PCOS only, have more severe clinical and biochemical features of PCOS and impaired QoL.
Study design: Observational cross-sectional study.Setting: A secondary care PCOS clinic in the WISDEM Centre, University Hospital Coventry.
Study outcomes: 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.
Methods: 158 women with PCOS will be recruited from the PCOS clinic. 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 (WHOQOL-BREF) questionnaire] will be compared between the two groups.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0469
Date of REC Opinion
6 Dec 2016
REC opinion
Further Information Favourable Opinion