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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using a CPAP machine, which keeps airways open during sleep, can improve conditions in pregnant women who snore but do not have sleep apnea. Researchers aim to determine if this treatment can also aid in managing preeclampsia, a condition marked by high blood pressure during pregnancy. Participants will use either the CPAP machine or nasal strips while sleeping. Pregnant women who snore, have a BMI over 30, and are early in pregnancy might be suitable candidates. The trial seeks to uncover connections between sleep issues and pregnancy complications. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance pregnancy outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that positive airway pressure is safe for sleep apnea?

Research has shown that Positive Airway Pressure (PAP) is generally safe for people. Studies have found that PAP can greatly improve conditions like obstructive sleep apnea. For instance, one study found that PAP treatment reduced sleepiness and lowered blood pressure. Another study noted that people using PAP had lower rates of death and serious heart issues.

While some users might experience minor problems, like skin irritation from the mask, serious side effects are rare. Overall, PAP is well-tolerated, and its benefits usually outweigh the risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using positive airway pressure (PAP) for sleep apnea because it offers a non-invasive way to keep airways open during sleep. Unlike traditional treatments like oral appliances or surgery, PAP uses a steady stream of air delivered through a mask to maintain an open airway. This technique can be immediately effective, improving sleep quality from the first night of use. Additionally, combining PAP with nasal dilator strips could enhance comfort and ease of use, potentially increasing adherence and overall treatment success.

What evidence suggests that positive airway pressure is effective for sleep apnea?

Research has shown that positive airway pressure (PAP) therapy effectively treats obstructive sleep apnea. Studies have found that PAP therapy greatly reduces the condition's severity, decreases daytime sleepiness, and lowers blood pressure. Adherence to PAP therapy is linked to a significant drop in heart-related deaths and problems. Strong evidence indicates that it reduces breathing interruptions during sleep and improves overall symptoms, making PAP a widely accepted treatment for sleep apnea. Participants in this trial may receive PAP therapy combined with nasal dilator strips or nasal dilator strips alone. ^{1 2 3 6 7}

Who Is on the Research Team?

Ghada Bourjeily, MD

Principal Investigator

The Miriam Hospital

Are You a Good Fit for This Trial?

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.

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

Intention to reside locally and deliver at Women and Infants Hospital of Rhode Island

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10838662/

Positive airway pressure therapy adherence and outcomes in ... Observational studies have found a significant reduction in CV mortality and decreased risk of CV events with greater adherence to PAP therapy.

2. cjrt.ca cjrt.ca/article/92080-positive-airway-pressure-therapy-adherence-and-outcomes-in-obstructive-sleep-apnea-an-exploratory-longitudinal-retrospective-randomized-chart-review

Positive airway pressure therapy adherence and outcomes ... Observational studies have found a significant reduction in CV mortality29 and decreased risk of CV events30,31 with greater adherence to PAP ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6374080/

Treatment of Adult Obstructive Sleep Apnea With Positive ... The data demonstrated that PAP compared to no treatment results in a clinically significant reduction in disease severity, sleepiness, blood pressure, and motor ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823539

Positive Airway Pressure, Mortality, and CV Risk in Older ... This cohort study evaluates whether positive airway pressure use is associated with lower mortality and incidence of major adverse ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212534524000790

Assessment and management of continuous positive ... CPAP is a highly effective treatment for OSA and is supported by extensive evidence of its efficacy in reducing apneas, alleviating symptoms, and addressing ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1389945724001096

Real-world impact of continuous positive airway pressure ... After starting CPAP treatment, the overall median (IQR) ESS score decreased (improved) by 2 (6) points from baseline to follow-up, and mean ESS scores decreased ...

7. thelancet.com thelancet.com/journals/ebiom/article/PIIS2352-3964(24)00087-2/fulltext

May continuous positive airway pressure (CPAP) treatment ... CPAP treatment would reduce this risk by correcting the hypoxic burden and sleep fragmentation. However, randomized controlled trials failed to ...