Positive Airway Pressure for Sleep Apnea

(PAP-SAP Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The Miriam Hospital

Disqualifiers: Incompetent cervix, Cardiac disease, Lung disease, Hypertension, others

Compensation: Varies

Number of Visits: 1

Duration: up to 6 months

262 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ghada Bourjeily, MD

Principal Investigator

The Miriam Hospital

Eligibility Criteria

This trial is for pregnant women who snore, are obese (BMI >30), over 18 years old, less than 13 weeks into their pregnancy, planning to deliver at Women and Infants Hospital of Rhode Island, and can consent. It's not for those with severe illnesses or conditions that affect participation, risk of preterm delivery due to incompetent cervix, intolerance to PAP therapy, drowsy driving issues, extreme low oxygen levels during sleep study, fetuses with congenital anomalies, severe high blood pressure at enrollment or serious heart/lung diseases.

Inclusion Criteria

Pregnant people who snore and don't have sleep apnea, and have a high body mass index (BMI) are not allowed to participate.

You are over 18 years old.

Gestational age <13 weeks (confirmed by last menstrual period or early pregnancy dating ultrasound)

Exclusion Criteria

Unable to meet inclusion criteria

Serious physical or mental illness or condition that would affect participation

You had a procedure called cerclage for a weak cervix, which could cause very early delivery and affect the study goals.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either nasal dilator strips or CPAP therapy with nasal dilator strips

up to 6 months

Periodic phone calls and remote monitoring

Follow-up

Participants are monitored for changes in placental histopathology and adverse pregnancy outcomes

8 months, delivery and 2 weeks postpartum

Placenta collected at delivery

Treatment Details

Interventions

• Positive Airway Pressure

Trial Overview The PAP-SAP study is examining if using continuous positive airway pressure (CPAP) therapy can improve the health and function of the placenta in pregnant women who snore but don't have obstructive sleep apnea. The research aims to find connections between sleep apnea and preeclampsia by looking at changes in the placenta.

Participant Groups

Group I: Positive Airway Pressure Active Control 2 Interventions

Positive airway pressure and nasal dilator strips during sleep.

Group II: Nasal Dilator Strips Placebo Group 1 Intervention

Nasal dilator strips during sleep.

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Rhode Island Hospital

Collaborator

Trials

275

Recruited

71,400+

Women and Infants Hospital of Rhode Island

Collaborator

Trials

119

Recruited

59,200+