PCOSSNORESNCT02442999
The SNORES Randomized Clinical Trial
A study testing Screening for obstructive sleep apnea and CPAP - continuous positive airway pressure in people with PCOS and Sleep Apnea, run by University of South Florida at 6 sites in United States.
Trial summary
Randomized clinical trial among women with polycystic ovary syndrome (PCOS) who present for fertility treatment to evaluate the impact of screening for obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS, Sleep Apnea
- What is being tested?
- Screening for obstructive sleep apnea and CPAP - continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2016to May 2017
- Phase
- Interventional
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females 18 - 50 years old.
- Receiving care from an Obstetrician / gynecologist or a Reproductive endocrinology infertility specialist
- Polycystic ovarian syndrome defined by the modified Rotterdam criteria
- Able to speak and understand as well as give informed consent in English
Who cannot join
- Late onset congenital adrenal hyperplasia
- Cushings disease
- Androgen-secreting tumors
- Previous diagnosis of obstructive sleep apnea
- Current use of over the counter or prescribed sleep medications.
- Examples of medications that exclude a patient from this study include but are not limited to Unisom, Ambien or Lunesta.
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- Patients who are taking non-prescribed herbal medications for sleep will not be excluded from the study. Examples of these include but are not limited to melatonin, chamomile, or valerian.
- Untreated thyroid disease
- Prolactin excess
- Patients with the following medical conditions will be excluded from the study as portable sleep apnea monitors are not indicated in patients with severe pulmonary disease, neuromuscular disease, or congestive heart failure.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
USF REI Lakeland
Lakeland, Florida, 33805
USF REI Sarasota
Sarasota, Florida, 34239
USF REI St. Petersburg
St. Petersburg, Florida, 33701
USF South Tampa Center
Tampa, Florida, 33606
USF Morsani
Tampa, Florida, 33612
USF REI Wesley Chapel
Wesley Chapel, Florida, 33544
About this study
Official title: Sleep Apnea in Non-ovulating REI Patients: The SNORES Randomized Clinical Trial
Randomized clinical trial among women with polycystic ovary syndrome (PCOS) who present for fertility treatment to evaluate the impact of screening for obstructive sleep apnea.
Read the detailed description
The investigators' goal is to perform a randomized clinical trial among women with PCOS who present for infertility treatment. Our primary outcome is to determine if screening women with PCOS, and treating those with confirmed sleep apnea, will lead to more ovulatory cycles. Our sub-aims are to describe the rate of OSA and sleep symptoms in patients with PCOS, to see if current sleep questionnaires correlate to a diagnostic sleep study, to describe the correlation between OSA and biomarkers of glucose homeostasis in women with PCOS, to investigate health related quality of life between the groups, to compare perinatal outcomes between the groups, and to evaluate the composition of breastmilk among women who choose to breastfeed.
- Conditions
- PCOS, Sleep Apnea
- Being tested
- Screening for obstructive sleep apnea, CPAP - continuous positive airway pressure
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for obstructive sleep apneaOther
CPAP - continuous positive airway pressureDevice
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Not described |
| Screen for Sleep Apnea | Experimental | Screen for sleep apnea, treat with continuous positive airway pressure (CPAP) if diagnosed with sleep apnea Receives: Other: Screening for obstructive sleep apnea; Device: CPAP - continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulatory cycles
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startJan 2016
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442999
- Sponsor's protocol ID
- Pro00020545
- Acronym
- SNORES
- Status last verified
- May 2017
- First submitted
- 13 Apr 2015
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea in Non-ovulating REI Patients: The SNORES Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02442999
- Acronym / sponsor ID
- SNORES / Pro00020545
- Conditions
- PCOS, Sleep Apnea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 May 2015 (estimated)
- 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.
Randomized clinical trial among women with polycystic ovary syndrome (PCOS) who present for fertility treatment to evaluate the impact of screening for obstructive sleep apnea.
Detailed description
The investigators' goal is to perform a randomized clinical trial among women with PCOS who present for infertility treatment. Our primary outcome is to determine if screening women with PCOS, and treating those with confirmed sleep apnea, will lead to more ovulatory cycles. Our sub-aims are to describe the rate of OSA and sleep symptoms in patients with PCOS, to see if current sleep questionnaires correlate to a diagnostic sleep study, to describe the correlation between OSA and biomarkers of glucose homeostasis in women with PCOS, to investigate health related quality of life between the groups, to compare perinatal outcomes between the groups, and to evaluate the composition of breastmilk among women who choose to breastfeed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | – |
| Screen for Sleep Apnea | Experimental | Other: Screening for obstructive sleep apnea, Device: CPAP - continuous positive airway pressureScreen for sleep apnea, treat with continuous positive airway pressure (CPAP) if diagnosed with sleep apnea |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females 18 - 50 years old.
- Receiving care from an Obstetrician / gynecologist or a Reproductive endocrinology infertility specialist
- Polycystic ovarian syndrome defined by the modified Rotterdam criteria
- Able to speak and understand as well as give informed consent in English
Key exclusion criteria (10 listed)
- Late onset congenital adrenal hyperplasia
- Cushings disease
- Androgen-secreting tumors
- Previous diagnosis of obstructive sleep apnea
- Current use of over the counter or prescribed sleep medications.
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 |
|---|---|---|
| Screening for obstructive sleep apnea | Other | Screen for Sleep Apnea |
| CPAP - continuous positive airway pressure | Device | Screen for Sleep Apnea |
Primary outcome
Ovulatory cycles
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening for obstructive sleep apnea and CPAP - continuous positive airway pressure in people with PCOS and Sleep Apnea, run by University of South Florida at 6 sites in United States.
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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 was stopped early (reason given: Poor enrollment). Results are not available in the source record.
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?
Ovulatory cycles (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2017.