Obstructive Sleep ApneaPAP-SAPNCT02412696
Positive Airway Pressure, Sleep Apnea, and the Placenta (PAP-SAP)
A study testing Positive Airway Pressure and Nasal Dilator Strips in people with Obstructive Sleep Apnea and Pregnancy, run by The Miriam Hospital at 1 site in United States.
Trial summary
This study is testing the hypothesis of whether continuous positive airway pressure (CPAP) therapy improves placental histopathology and secretory function. The main aims of the study are to identify shared mechanisms between obstructive sleep apnea and preeclampsia, both common highly morbid conditions. 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
- What is being tested?
- Positive Airway Pressure and Nasal Dilator Strips
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to 1 May 2025
- Phase
- Interventional
- 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
Who may be able to join
- Pregnant snorers without obstructive sleep apnea, have a BMI >30 kg/m2 at recruitment
- >18 years of age
- <13 completed weeks of gestation (confirmed by last menstrual period or early pregnancy dating ultrasound during qualification)
- Intention to reside locally and deliver at Women and Infants Hospital of Rhode Island
- Ability to give informed consent.
Who cannot join
- Unable to meet inclusion criteria, Incompetent cervix / cerclage (likelihood of severe preterm delivery affecting study aims)
- Inability to tolerate PAP therapy
- Serious physical or mental illness or condition that would affect participation
- Drowsy driving
- Severe hypoxemia on sleep study
- Advanced cardiac disease or arrhythmias that may benefit from PAP therapy
Show all 10Show fewer
- Chronic lung disease and / or respiratory failure.
- Twin pregnancies
- Fetuses with congenital anomalies
- Severe hypertension at enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placental Role in Mediating Adverse Outcomes in Obstructive Sleep Apnea
This study is testing the hypothesis of whether continuous positive airway pressure (CPAP) therapy improves placental histopathology and secretory function. The main aims of the study are to identify shared mechanisms between obstructive sleep apnea and preeclampsia, both common highly morbid conditions.
Read the detailed description
Patients will be recruited from multiple community and hospital-based practices that care for pregnant women. Subjects will be given a physical exam, have measurements taken, answer questionnaires and then will be screened using a home sleep apnea test (HSAT) Type III device. Those diagnosed with Obstructive Sleep Apnea will then be randomized to one of two groups (below).
Both groups will have:
- blood testing for placenta-secreted circulating markers
- placental histopathological and immunohistochemistry examination of placental expression of markers.
Both groups will answer sleep and mood questionnaires, have blood pressure, blood glucose and activity / sleep watch monitoring and will receive an educational session on pregnancy health.
Randomization groups include:
- Nasal dilator strips: Participants receiving nasal dilator strips will be monitored by need for refill of supplies and periodic phone calls.
- CPAP + nasal dilator strips: Subjects randomized to positive airway pressure (PAP) therapy will receive auto-titrating PAP. Pressure requirements will be monitored remotely and pressure modified as needed. PAP adherence will be determined subjectively and objectively. This group will also receive nasal dilator strips as described above.
All subjects will receive small gift incentives such as baby-related items. Monetary incentives will also be issued at data collection points.
- Conditions
- Obstructive Sleep Apnea, Pregnancy, Obesity, Preeclampsia, Sleep
- Being tested
- Positive Airway Pressure, Nasal Dilator Strips
- Keywords
- placental morphology, CPAP, placental secretory function
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Airway PressureDevice
Auto-titrating PAP + nasal dilator strips during sleep
Nasal Dilator StripsOther
Nasal dilator strips
| Study group | Role | What they receive |
|---|---|---|
| Positive Airway Pressure | Active comparator | Positive airway pressure and nasal dilator strips during sleep. Receives: Device: Positive Airway Pressure; Other: Nasal Dilator Strips |
| Nasal Dilator Strips | Placebo comparator | Nasal dilator strips during sleep. Receives: Other: Nasal Dilator Strips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alterations in circulating placenta-secreted markers.
Placenta secreted markers that have been linked to preeclampsia as well as angiogenic and anti-angiogenic markers will be measured longitudinally during the course of pregnancy.
Measured: up to 6 months
Changes in placental histopathology for markers of malperfusion and placental expression of markers
Placental morphology and histopathology will be examined by 3 perinatal pathologists, blinded to each other's reading and to intervention arm. Immunohistochemistry will be used to examine placental expression of certain markers.
Measured: Placenta collected at time of delivery
Secondary outcomes (2)
Change in 24-hour Ambulatory mean diurnal and nocturnal blood pressure measurements
A 24 blood pressure monitor will be used to measure changes in daytime and nighttime average blood pressure.
Measured: Prior to randomization, then at approximately 3 months, and 6 months later
Change in a composite of adverse pregnancy outcomes
Pregnancy outcomes defined as gestational hypertension, gestational diabetes and preterm birth (birth prior to 37 completed weeks of pregnancy will be analyzed as a composite outcome
Measured: 8 months, delivery and 2 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study start1 Jun 2015
- Primary completion1 Aug 2020
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 262 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, Brigham and Women's Hospital
- 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
- NCT02412696
- Sponsor's protocol ID
- 1R01HD078515-01A1
- Acronym
- PAP-SAP
- Status last verified
- Nov 2024
- First submitted
- 21 Jan 2015
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sanapo 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 34999843Facco F. Sleep Duration, Sleep Timing, and Sleep Disordered Breathing-Associations With Obesity and Gestational Diabetes in Pregnancy. Clin Obstet Gynecol. 2021 Mar 1;64(1):196-203. doi: 10.1097/GRF.0000000000000587.
PubMed 33481418
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
- Placental Role in Mediating Adverse Outcomes in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02412696
- Acronym / sponsor ID
- PAP-SAP / 1R01HD078515-01A1
- Conditions
- Obstructive Sleep Apnea, Pregnancy, Obesity, Preeclampsia, Sleep
- Keywords
- placental morphology, CPAP, placental secretory function
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Brown University, Rhode Island Hospital, Women and Infants Hospital of Rhode Island, Brigham and Women's Hospital
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 9 Apr 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.
This study is testing the hypothesis of whether continuous positive airway pressure (CPAP) therapy improves placental histopathology and secretory function. The main aims of the study are to identify shared mechanisms between obstructive sleep apnea and preeclampsia, both common highly morbid conditions.
Detailed description
Patients will be recruited from multiple community and hospital-based practices that care for pregnant women. Subjects will be given a physical exam, have measurements taken, answer questionnaires and then will be screened using a home sleep apnea test (HSAT) Type III device. Those diagnosed with Obstructive Sleep Apnea will then be randomized to one of two groups (below).
Both groups will have:
- blood testing for placenta-secreted circulating markers
- placental histopathological and immunohistochemistry examination of placental expression of markers.
Both groups will answer sleep and mood questionnaires, have blood pressure, blood glucose and activity / sleep watch monitoring and will receive an educational session on pregnancy health.
Randomization groups include:
- Nasal dilator strips: Participants receiving nasal dilator strips will be monitored by need for refill of supplies and periodic phone calls.
- CPAP + nasal dilator strips: Subjects randomized to positive airway pressure (PAP) therapy will receive auto-titrating PAP. Pressure requirements will be monitored remotely and pressure modified as needed. PAP adherence will be determined subjectively and objectively. This group will also receive nasal dilator strips as described above.
All subjects will receive small gift incentives such as baby-related items. Monetary incentives will also be issued at data collection points.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Airway Pressure | Active comparator | Device: Positive Airway Pressure, Other: Nasal Dilator StripsPositive airway pressure and nasal dilator strips during sleep. |
| Nasal Dilator Strips | Placebo comparator | Other: Nasal Dilator StripsNasal dilator strips during sleep. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant snorers without obstructive sleep apnea, have a BMI >30 kg/m2 at recruitment
- >18 years of age
- <13 completed weeks of gestation (confirmed by last menstrual period or early pregnancy dating ultrasound during qualification)
- Intention to reside locally and deliver at Women and Infants Hospital of Rhode Island
- Ability to give informed consent.
Key exclusion criteria (10 listed)
- Unable to meet inclusion criteria, Incompetent cervix / cerclage (likelihood of severe preterm delivery affecting study aims)
- Inability to tolerate PAP therapy
- Serious physical or mental illness or condition that would affect participation
- Drowsy driving
- Severe hypoxemia on sleep study
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 |
|---|---|---|
| Positive Airway PressureAuto-titrating PAP + nasal dilator strips during sleep | Device | Positive Airway Pressure |
| Nasal Dilator StripsNasal dilator strips | Other | Nasal Dilator Strips, Positive Airway Pressure |
Primary outcome
Alterations in circulating placenta-secreted markers.
Time frame: up to 6 months
Placenta secreted markers that have been linked to preeclampsia as well as angiogenic and anti-angiogenic markers will be measured longitudinally during the course of pregnancy.
Changes in placental histopathology for markers of malperfusion and placental expression of markers
Time frame: Placenta collected at time of delivery
Placental morphology and histopathology will be examined by 3 perinatal pathologists, blinded to each other's reading and to intervention arm. Immunohistochemistry will be used to examine placental expression of certain markers.
2 secondary outcomes
Change in 24-hour Ambulatory mean diurnal and nocturnal blood pressure measurements
Time frame: Prior to randomization, then at approximately 3 months, and 6 months later
Change in a composite of adverse pregnancy outcomes
Time frame: 8 months, delivery and 2 weeks postpartum
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 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.
- Derived from this study: PubMed 33481418Facco F. Sleep Duration, Sleep Timing, and Sleep Disordered Breathing-Associations With Obesity and Gestational Diabetes in Pregnancy. Clin Obstet Gynecol. 2021 Mar 1;64(1):196-203. doi: 10.1097/GRF.0000000000000587.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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?
A study testing Positive Airway Pressure and Nasal Dilator Strips in people with 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 5 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: 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. Some participants in this study may receive a placebo. 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?
Alterations in circulating placenta-secreted markers. (time frame: up to 6 months). The study lists 2 primary outcomes in all. 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 NCT02412696, 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.