Clinical trial NCT02412696: Positive Airway Pressure, Sleep Apnea, and the Placenta (PAP-SAP)
Official title: Placental Role in Mediating Adverse Outcomes in Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Pregnancy
Obesity
Preeclampsia
Sleep
Keywords: placental morphology
CPAP
placental secretory function
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
name: Rhode Island Hospital
name: Women and Infants Hospital of Rhode Island
name: Brigham and Women's Hospital
First posted: 2015-04-09
Enrollment: 262
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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:

1. blood testing for placenta-secreted circulating markers
2. 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:

1. Nasal dilator strips: Participants receiving nasal dilator strips will be monitored by need for refill of supplies and periodic phone calls.
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Alterations in circulating placenta-secreted markers.
timeFrame: up to 6 months
measure: Changes in placental histopathology for markers of malperfusion and placental expression of markers
timeFrame: Placenta collected at time of delivery
Secondary outcomes:
measure: Change in 24-hour Ambulatory mean diurnal and nocturnal blood pressure measurements
timeFrame: Prior to randomization, then at approximately 3 months, and 6 months later
measure: Change in a composite of adverse pregnancy outcomes
timeFrame: 8 months, delivery and 2 weeks postpartum
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Ghada Bourjeily, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Facco 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.