Sleep ApneaSAPSSNCT01585844
Sleep Apnea in Pregnancy Screening Study
An observational study of Sleep Apnea and Obesity, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
Obstructive sleep apnea is known to be a significant source of morbidity in the general population. It has been proposed to be associated with the development of preeclampsia and fetal growth restriction. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obesity
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Apr 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obstetric care clinic at a tertiary care hospital
Who may be able to join
- Prepregnancy BMI of 30kg/m2 or greater
- Singleton pregnancy
- 18 years or older
Who cannot join
- Chronic use of narcotics or other CNS drugs
- Inability to sleep beyond 2 hours
- 3 or more missed prenatal visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obstructive Sleep Apnea in Pregnancy:Epidemiology and Maternal/ Neonatal Morbidity
Obstructive sleep apnea is known to be a significant source of morbidity in the general population. It has been proposed to be associated with the development of preeclampsia and fetal growth restriction. As these are conditions that have long term maternal and neonatal implications, further information may help improve maternal/fetal outcome. One reason why women and in particular pregnant women are under diagnosed is the lack of an effective, reliable screening tool. Validated questionnaires used in the general population may not be effective in screening pregnant women. The investigators hypothesize that sleep apnea will have 20% prevalence in the obese pregnant population and that it is associated with increased maternal and neonatal morbidity. The investigators will recruit obese pregnant women in their prenatal care clinics and they will be screened for OSA using validated sleep questionnaires including the Epworth sleepiness scale, the Fatigue Scale and the Berlin Questionnaire. The subjects will then perform overnight apnea monitoring utilizing a portable sleep apnea detection device. Women who meet clinical criteria for OSA will be referred for overnight polysomnogram and management by the Pulmonary and Critical Care Division of the Internal Medicine Department. For all enrolled patients the remainder of prenatal care will be per routine. Data will be collected regarding the pregnancy course and outcomes.
The primary outcome of interest is the prevalence of sleep apnea in obese women and the associated maternal and neonatal morbidity. The secondary outcome measures will be molecular measures of systemic inflammation, oxidative stress and angiogenesis associated with sleep apnea.
- Conditions
- Sleep Apnea, Obesity
- Keywords
- sleep apnea, pregnancy, obesity
- Medical subject headings
- Sleep Apnea Syndromes, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with sleep apnea | Not described | |
| Women without sleep apnea | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of sleep apnea in obese pregnant women
Measured: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks
Secondary outcomes (2)
Alterations in biomarkers of inflammation and oxidative stress
Measured: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks
The prevalence of maternal and neonatal morbidity
Measured: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startAug 2008
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Judette Louis, MD, MPH, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585844
- Sponsor's protocol ID
- RWJ64323
- Acronym
- SAPSS
- Status last verified
- Apr 2012
- First submitted
- 23 Apr 2012
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Connolly G, Razak AR, Hayanga A, Russell A, McKenna P, McNicholas WT. Inspiratory flow limitation during sleep in pre-eclampsia: comparison with normal pregnant and nonpregnant women. Eur Respir J. 2001 Oct;18(4):672-6. doi: 10.1183/09031936.01.00053501.
PubMed 11716173Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.
PubMed 11991871Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
PubMed 8464434Joel-Cohen SJ, Schoenfeld A. Fetal response to periodic sleep apnea: a new syndrome in obstetrics. Eur J Obstet Gynecol Reprod Biol. 1978 Apr;8(2):77-81. doi: 10.1016/0028-2243(78)90131-4.
PubMed 45501Franklin KA, Holmgren PA, Jonsson F, Poromaa N, Stenlund H, Svanborg E. Snoring, pregnancy-induced hypertension, and growth retardation of the fetus. Chest. 2000 Jan;117(1):137-41. doi: 10.1378/chest.117.1.137.
PubMed 10631211Charbonneau M, Falcone T, Cosio MG, Levy RD. Obstructive sleep apnea during pregnancy. Therapy and implications for fetal health. Am Rev Respir Dis. 1991 Aug;144(2):461-3. doi: 10.1164/ajrccm/144.2.461.
PubMed 1859076Louis JM, Auckley D, Sokol RJ, Mercer BM. Maternal and neonatal morbidities associated with obstructive sleep apnea complicating pregnancy. Am J Obstet Gynecol. 2010 Mar;202(3):261.e1-5. doi: 10.1016/j.ajog.2009.10.867. Epub 2009 Dec 14.
PubMed 20005507Pien GW, Fife D, Pack AI, Nkwuo JE, Schwab RJ. Changes in symptoms of sleep-disordered breathing during pregnancy. Sleep. 2005 Oct;28(10):1299-305. doi: 10.1093/sleep/28.10.1299.
PubMed 16295215
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea in Pregnancy:Epidemiology and Maternal/ Neonatal Morbidity
- ClinicalTrials.gov ID
- NCT01585844
- Acronym / sponsor ID
- SAPSS / RWJ64323
- Conditions
- Sleep Apnea, Obesity
- Keywords
- sleep apnea, pregnancy, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Aug 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 26 Apr 2012 (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.
Obstructive sleep apnea is known to be a significant source of morbidity in the general population. It has been proposed to be associated with the development of preeclampsia and fetal growth restriction. As these are conditions that have long term maternal and neonatal implications, further information may help improve maternal/fetal outcome. One reason why women and in particular pregnant women are under diagnosed is the lack of an effective, reliable screening tool. Validated questionnaires used in the general population may not be effective in screening pregnant women. The investigators hypothesize that sleep apnea will have 20% prevalence in the obese pregnant population and that it is associated with increased maternal and neonatal morbidity. The investigators will recruit obese pregnant women in their prenatal care clinics and they will be screened for OSA using validated sleep questionnaires including the Epworth sleepiness scale, the Fatigue Scale and the Berlin Questionnaire. The subjects will then perform overnight apnea monitoring utilizing a portable sleep apnea detection device. Women who meet clinical criteria for OSA will be referred for overnight polysomnogram and management by the Pulmonary and Critical Care Division of the Internal Medicine Department. For all enrolled patients the remainder of prenatal care will be per routine. Data will be collected regarding the pregnancy course and outcomes.
The primary outcome of interest is the prevalence of sleep apnea in obese women and the associated maternal and neonatal morbidity. The secondary outcome measures will be molecular measures of systemic inflammation, oxidative stress and angiogenesis associated with sleep apnea.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with sleep apnea | – | – |
| Women without sleep apnea | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obstetric care clinic at a tertiary care hospital
Key inclusion criteria (3 listed)
- Prepregnancy BMI of 30kg/m2 or greater
- Singleton pregnancy
- 18 years or older
Key exclusion criteria (3 listed)
- Chronic use of narcotics or other CNS drugs
- Inability to sleep beyond 2 hours
- 3 or more missed prenatal visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of sleep apnea in obese pregnant women
Time frame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks
2 secondary outcomes
Alterations in biomarkers of inflammation and oxidative stress
Time frame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks
The prevalence of maternal and neonatal morbidity
Time frame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks
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 14 Nov 2023.
- Background: PubMed 11716173Connolly G, Razak AR, Hayanga A, Russell A, McKenna P, McNicholas WT. Inspiratory flow limitation during sleep in pre-eclampsia: comparison with normal pregnant and nonpregnant women. Eur Respir J. 2001 Oct;18(4):672-6. doi: 10.1183/09031936.01.00053501.
- Background: PubMed 11991871Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.
- Background: PubMed 8464434Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
- Background: PubMed 45501Joel-Cohen SJ, Schoenfeld A. Fetal response to periodic sleep apnea: a new syndrome in obstetrics. Eur J Obstet Gynecol Reprod Biol. 1978 Apr;8(2):77-81. doi: 10.1016/0028-2243(78)90131-4.
- Background: PubMed 10631211Franklin KA, Holmgren PA, Jonsson F, Poromaa N, Stenlund H, Svanborg E. Snoring, pregnancy-induced hypertension, and growth retardation of the fetus. Chest. 2000 Jan;117(1):137-41. doi: 10.1378/chest.117.1.137.
- Background: PubMed 1859076Charbonneau M, Falcone T, Cosio MG, Levy RD. Obstructive sleep apnea during pregnancy. Therapy and implications for fetal health. Am Rev Respir Dis. 1991 Aug;144(2):461-3. doi: 10.1164/ajrccm/144.2.461.
- Background: PubMed 20005507Louis JM, Auckley D, Sokol RJ, Mercer BM. Maternal and neonatal morbidities associated with obstructive sleep apnea complicating pregnancy. Am J Obstet Gynecol. 2010 Mar;202(3):261.e1-5. doi: 10.1016/j.ajog.2009.10.867. Epub 2009 Dec 14.
- Background: PubMed 16295215Pien GW, Fife D, Pack AI, Nkwuo JE, Schwab RJ. Changes in symptoms of sleep-disordered breathing during pregnancy. Sleep. 2005 Oct;28(10):1299-305. doi: 10.1093/sleep/28.10.1299.
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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.
Judette Louis, MD, MPH principal investigator
MetroHealth Medical Center
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 Sleep Apnea and Obesity, run by MetroHealth Medical Center at 1 site 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 3 inclusion and 3 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 14 Nov 2023. 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 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 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?
The prevalence of sleep apnea in obese pregnant women (time frame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks). 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 NCT01585844, which also lists 8 linked publications.
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 14 Nov 2023.