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Device

Positive Airway Pressure for Sleep Apnea (PAP-SAP Trial)

N/A
Waitlist Available
Led By Ghada Bourjeily, MD
Research Sponsored by The Miriam Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months, delivery and 2 weeks postpartum

Summary

This trial is testing whether CPAP therapy can improve the health of the placenta in pregnant women with sleep apnea.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While CPAP is generally considered safe for pregnant women when properly monitored by healthcare professionals; potential side effects may include discomfort from wearing the mask such as skin irritation or nasal congestion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months, delivery and 2 weeks postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months, delivery and 2 weeks postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Alterations in circulating placenta-secreted markers.
Changes in placental histopathology for markers of malperfusion and placental expression of markers
Secondary study objectives
Change in 24-hour Ambulatory mean diurnal and nocturnal blood pressure measurements
Change in a composite of adverse pregnancy outcomes

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Positive Airway PressureActive Control2 Interventions
Positive airway pressure and nasal dilator strips during sleep.
Group II: Nasal Dilator StripsPlacebo Group1 Intervention
Nasal dilator strips during sleep.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalOTHER
1,666 Previous Clinical Trials
11,839,973 Total Patients Enrolled
11 Trials studying Sleep
13,347 Patients Enrolled for Sleep
The Miriam HospitalLead Sponsor
244 Previous Clinical Trials
37,616 Total Patients Enrolled
5 Trials studying Sleep
750 Patients Enrolled for Sleep
Brown UniversityOTHER
466 Previous Clinical Trials
698,808 Total Patients Enrolled
3 Trials studying Sleep
586 Patients Enrolled for Sleep

Media Library

Positive Airway Pressure (Device) Clinical Trial Eligibility Overview. Trial Name: NCT02412696 — N/A
Sleep Research Study Groups: Positive Airway Pressure, Nasal Dilator Strips
Sleep Clinical Trial 2023: Positive Airway Pressure Highlights & Side Effects. Trial Name: NCT02412696 — N/A
Positive Airway Pressure (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02412696 — N/A
~25 spots leftby Nov 2025
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