Obstructive Sleep ApneaPredictorsNCT02917876
Predictors of De-novo Development of Obstructive Sleep Apnea in Pregnancy
An observational study of Obstructive Sleep Apnea and Pregnancy, run by The Miriam Hospital at 1 site in United States.
Trial summary
This study seeks to understand the physical, physiologic and biologic features that predispose a woman to the development of obstructive sleep apnea once they are exposed to the cardiopulmonary and metabolic physiological changes of pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstructive Sleep Apnea, Pregnancy, Obesity
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 1 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Pregnant women, 18 years or older, at less than 13 completed weeks of gestation and who have a BMI that is greater than 30 kg/m2 at recruitment.
Who may be able to join
- <13 completed weeks of gestation
- BMI >30 kg/m2 at recruitment
- >18 years of age
- Ability to give informed consent
Who cannot join
- Unable to meet inclusion criteria
- Twin pregnancies
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to understand the physical, physiologic and biologic features that predispose a woman to the development of obstructive sleep apnea once they are exposed to the cardiopulmonary and metabolic physiological changes of pregnancy. Knowing these specific predictive factors can help identify a population at risk and guide clinicians to develop suitable targeting screening strategies.
Read the detailed description
Patients will be recruited from multiple community and hospital-based practices that care for pregnant women. Subjects will have:
- measurements of body composition
- anthropometric measures
- sleep and mood questionnaires
- Home sleep studies
- blood testing for biological markers
- salivary testing for hormonal markers
- pulmonary function tests and upper airway patency measurements
Women without sleep apnea at enrollment will then be followed longitudinally for the development of obstructive sleep apnea during pregnancy with repeat assessment during their third trimester. Women diagnosed with sleep apnea at enrollment will have no further assessment in late pregnancy.
Monetary incentives will also be issued at data collection points. Subjects will receive small gift incentives such as baby-related items.
- Conditions
- Obstructive Sleep Apnea, Pregnancy, Obesity, Sleep
- Keywords
- Obstructive Sleep Apnea, Pregnancy, Obesity, Fluid shifts, Body composition, Sleep
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of participants who develop obstructive sleep apnea defined as an apnea hypopnea index >5 events per hour
The study will develop a model of biologic, physiologic and anthropometric measures that predict the development of obstructive sleep apnea apnea later in pregnancy compared to baseline in early pregnancy.
Measured: Up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startNov 2016
- Primary completion30 Dec 2023
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, Rhode Island Hospital, Women and Infants Hospital of Rhode Island
- Responsible party
- Principal investigator, Ghada Bourjeily, The Miriam Hospital
- Investigators
- Ghada Bourjeily, MD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917876
- Sponsor's protocol ID
- 1R01HL130702
- Acronym
- Predictors
- Status last verified
- Nov 2024
- First submitted
- 21 Sep 2016
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data for primary and secondary outcome measures will be made available.
Publications
Bublitz MH, Nillni Y, Nugent NR, Sanapo L, Habr N, Bourjeily G. Posttraumatic stress disorder, diurnal cortisol, and ambulatory blood pressure in early and late pregnancy. J Trauma Stress. 2023 Feb;36(1):239-246. doi: 10.1002/jts.22895. Epub 2022 Dec 4.
PubMed 36464928Sanapo L, Bublitz MH, Bai A, Mehta N, Messerlian GM, Catalano P, Bourjeily G. Association between sleep disordered breathing in early pregnancy and glucose metabolism. Sleep. 2022 Apr 11;45(4):zsab281. doi: 10.1093/sleep/zsab281.
PubMed 34999843
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of De-novo Development of Obstructive Sleep Apnea in Pregnancy
- ClinicalTrials.gov ID
- NCT02917876
- Acronym / sponsor ID
- Predictors / 1R01HL130702
- Conditions
- Obstructive Sleep Apnea, Pregnancy, Obesity, Sleep
- Keywords
- Obstructive Sleep Apnea, Pregnancy, Obesity, Fluid shifts, Body composition, Sleep
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Brown University, Rhode Island Hospital, Women and Infants Hospital of Rhode Island
- Study start
- Nov 2016
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 28 Sep 2016 (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.
This study seeks to understand the physical, physiologic and biologic features that predispose a woman to the development of obstructive sleep apnea once they are exposed to the cardiopulmonary and metabolic physiological changes of pregnancy. Knowing these specific predictive factors can help identify a population at risk and guide clinicians to develop suitable targeting screening strategies.
Detailed description
Patients will be recruited from multiple community and hospital-based practices that care for pregnant women. Subjects will have:
- measurements of body composition
- anthropometric measures
- sleep and mood questionnaires
- Home sleep studies
- blood testing for biological markers
- salivary testing for hormonal markers
- pulmonary function tests and upper airway patency measurements
Women without sleep apnea at enrollment will then be followed longitudinally for the development of obstructive sleep apnea during pregnancy with repeat assessment during their third trimester. Women diagnosed with sleep apnea at enrollment will have no further assessment in late pregnancy.
Monetary incentives will also be issued at data collection points. Subjects will receive small gift incentives such as baby-related items.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women, 18 years or older, at less than 13 completed weeks of gestation and who have a BMI that is greater than 30 kg/m2 at recruitment.
Key inclusion criteria (4 listed)
- <13 completed weeks of gestation
- BMI >30 kg/m2 at recruitment
- >18 years of age
- Ability to give informed consent
Key exclusion criteria (2 listed)
- Unable to meet inclusion criteria
- Twin pregnancies
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
Characteristics of participants who develop obstructive sleep apnea defined as an apnea hypopnea index >5 events per hour
Time frame: Up to 40 weeks
The study will develop a model of biologic, physiologic and anthropometric measures that predict the development of obstructive sleep apnea apnea later in pregnancy compared to baseline in early pregnancy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Derived from this study: PubMed 36464928Bublitz MH, Nillni Y, Nugent NR, Sanapo L, Habr N, Bourjeily G. Posttraumatic stress disorder, diurnal cortisol, and ambulatory blood pressure in early and late pregnancy. J Trauma Stress. 2023 Feb;36(1):239-246. doi: 10.1002/jts.22895. Epub 2022 Dec 4.
- Derived from this study: PubMed 34999843Sanapo L, Bublitz MH, Bai A, Mehta N, Messerlian GM, Catalano P, Bourjeily G. Association between sleep disordered breathing in early pregnancy and glucose metabolism. Sleep. 2022 Apr 11;45(4):zsab281. doi: 10.1093/sleep/zsab281.
- Individual participant dataSharing planned: Yes. De-identified data for primary and secondary outcome measures will be made available.
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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.
Ghada Bourjeily, MD principal investigator
The Miriam Hospital
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 Obstructive Sleep Apnea and Pregnancy, run by The Miriam Hospital 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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 22 Nov 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Characteristics of participants who develop obstructive sleep apnea defined as an apnea hypopnea index >5 events per hour (time frame: Up to 40 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 NCT02917876, which also lists 2 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 22 Nov 2024.