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

Obesity Clinical Trial

— PAP-SAP  

Official title:

Placental Role in Mediating Adverse Outcomes in Obstructive Sleep Apnea

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02412696
• Other study ID #: 1R01HD078515-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 262
• Est. completion date: December 1, 2024
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obesity
• Obstructive Sleep Apnea
• Pre-Eclampsia
• Preeclampsia
• Pregnancy
• Sleep
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Positive Airway Pressure
Auto-titrating PAP + nasal dilator strips during sleep

Other:
• Nasal Dilator Strips
Nasal dilator strips

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (5)

Lead Sponsor	Collaborator
The Miriam Hospital	Brigham and Women's Hospital, Brown University, Rhode Island Hospital, Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 6 months
Primary	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.	Placenta collected at time of delivery
Secondary	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.	Prior to randomization, then at approximately 3 months, and 6 months later
Secondary	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	8 months, delivery and 2 weeks postpartum