Polycystic Ovary SyndromeNCT03065322
The Impact of Obstructive Sleep Apnoea in Women With Polycystic Ovary Syndrome.
An observational study of Polycystic Ovary Syndrome and Obstructive Sleep Apnea, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Obstructive Sleep Apnea
- What is being tested?
- To assess risk of OSA
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Feb 2017to 1 Jan 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, West Midlands, CV2 2DX
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome, Obstructive Sleep Apnea
- Being tested
- To assess risk of OSA
- Keywords
- PCOS, OSA
- Medical subject headings
- Polycystic Ovary Syndrome, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To assess risk of OSAOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: To assess risk of OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day.
Secondary outcomes (7)
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Measured: One day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start13 Feb 2017
- Primary completion11 May 2018
- Study completion1 Jan 2019
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 Polycystic Ovary SyndromeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warwick
- Responsible party
- Sponsor
- Investigators
- Martin O Weickert, MD, FRCP, Principal investigator, University Hospitals Coventry and Warwickshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065322
- Sponsor's protocol ID
- MW181216
- Other IDs
- 213996
- Status last verified
- Jun 2024
- First submitted
- 12 Jan 2017
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32128106
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Obstructive Sleep Apnoea in Women With Polycystic Ovary Syndrome: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03065322
- Acronym / sponsor ID
- MW181216
- Conditions
- Polycystic Ovary Syndrome, Obstructive Sleep Apnea
- Keywords
- PCOS, OSA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Collaborators
- University of Warwick
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 27 Feb 2017 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with PCOS | – | Other: To assess risk of OSAWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To assess risk of OSAThe 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. | Other | Women with PCOS |
Primary outcome
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.
Time frame: One day.
Quality of life will be measured using the World Health Organisation QoL-BREF (WHOQOL-BREF) questionnaire.
7 secondary outcomes
Difference in BMI between women with PCOS and low risk of OSA compared to women with PCOS and OSA.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: One day
Difference in modified Ferriman-Gallwey score between women with PCOS and low risk of OSA compared to women with PCOS and OSA.
Time frame: 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.
Time frame: One day.
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 18 Jun 2024.
- Derived from this study: PubMed 32128106Kahal 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.
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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.
Martin O Weickert, MD, FRCP principal investigator
University Hospitals Coventry and Warwickshire NHS Trust
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 Polycystic Ovary Syndrome and Obstructive Sleep Apnea, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
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 6 inclusion and 5 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 18 Jun 2024. 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 United Kingdom. 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?
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. (time frame: One day.). 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 NCT03065322, 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 18 Jun 2024.