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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 months, delivery and 2 weeks postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months, delivery and 2 weeks postpartum
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.
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Who is running the clinical trial?
Brigham and Women's HospitalOTHER
1,659 Previous Clinical Trials
11,699,360 Total Patients Enrolled
The Miriam HospitalLead Sponsor
243 Previous Clinical Trials
37,445 Total Patients Enrolled
Brown UniversityOTHER
464 Previous Clinical Trials
698,540 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a procedure called cerclage for a weak cervix, which could cause very early delivery and affect the study goals.You cannot tolerate PAP (Positive Airway Pressure) therapy.Driving while feeling sleepy.You have very low levels of oxygen while sleeping.Unborn babies with birth defectsYou have very high blood pressure when you join the study.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.You have long-term lung disease or trouble breathing.You have severe heart disease or irregular heartbeats that could be helped by PAP therapy.You are pregnant with twins.
Research Study Groups:
This trial has the following groups:- Group 1: Positive Airway Pressure
- Group 2: Nasal Dilator Strips
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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