Positive Airway Pressure, Sleep Apnea, and the Placenta (PAP-SAP)

Sponsor

The Miriam Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02412696

Collaborator

Brown University (Other), Rhode Island Hospital (Other), Women and Infants Hospital of Rhode Island (Other), Brigham and Women's Hospital (Other)

262

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea Pregnancy Obesity Preeclampsia Sleep	Device: Positive Airway Pressure Other: Nasal Dilator Strips	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

262 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Placental Role in Mediating Adverse Outcomes in Obstructive Sleep Apnea

Actual Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Positive Airway Pressure Positive airway pressure and nasal dilator strips during sleep.	Device: Positive Airway Pressure Auto-titrating PAP + nasal dilator strips during sleep Other: Nasal Dilator Strips Nasal dilator strips
Placebo Comparator: Nasal Dilator Strips Nasal dilator strips during sleep.	Other: Nasal Dilator Strips Nasal dilator strips

Arm

Intervention/Treatment

Active Comparator: Positive Airway Pressure

Positive airway pressure and nasal dilator strips during sleep.

Device: Positive Airway Pressure

Auto-titrating PAP + nasal dilator strips during sleep

Other: Nasal Dilator Strips

Nasal dilator strips

Placebo Comparator: Nasal Dilator Strips

Nasal dilator strips during sleep.

Other: Nasal Dilator Strips

Nasal dilator strips

Outcome Measures

Primary Outcome Measures

Alterations in circulating placenta-secreted markers. [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 [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.

Secondary Outcome Measures

Change in 24-hour Ambulatory mean diurnal and nocturnal blood pressure measurements [Prior to randomization, then at approximately 3 months, and 6 months later]
A 24 blood pressure monitor will be used to measure changes in daytime and nighttime average blood pressure.
Change in a composite of adverse pregnancy outcomes [8 months, delivery and 2 weeks postpartum]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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
Chronic lung disease and / or respiratory failure.
Twin pregnancies
Fetuses with congenital anomalies
Severe hypertension at enrollment