CPAP for Sleep Apnea in Pregnancy

(SLEEP Trial)

Recruiting at 13 trial locations

Overseen By Maged Costantine, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The George Washington University Biostatistics Center

Must not be taking: Sleeping pills, Opiates

Disqualifiers: Asthma, Chronic renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Throughout pregnancy

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Continuous Positive Airway Pressure (CPAP) machines can reduce high blood pressure in pregnant women with sleep apnea. Participants will either use a CPAP machine, which keeps airways open during sleep, or receive sleep advice without the machine. Pregnant women between 14 and 21 weeks along, diagnosed with mild to moderate sleep apnea, are suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to important research that could enhance health outcomes for pregnant women with sleep apnea.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using prescribed sleeping pills, opiates, or require systemic steroid therapy for asthma. It's best to discuss your specific medications with the trial team.

What prior data suggests that CPAP is safe for use in pregnancy?

Research has shown that Continuous Positive Airway Pressure (CPAP) in pregnant women with obstructive sleep apnea (OSA) can reduce the risk of high blood pressure and other health issues during pregnancy. Importantly, studies have found no harmful effects of CPAP on pregnant women or their babies. CPAP is considered a safe treatment and offers long-term benefits for managing OSA. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Continuous Positive Airway Pressure (CPAP) for sleep apnea in pregnancy because it offers a non-invasive approach that could improve sleep quality without medication. Unlike other treatments that might involve drugs, CPAP uses a machine that provides a steady flow of air through a mask, keeping the airways open and reducing apnea episodes. This treatment is particularly appealing because it combines weekly support and incentives to encourage adherence, potentially leading to better outcomes for both the mother and baby. Additionally, the focus on autotitrating CPAP means the machine automatically adjusts the air pressure to the patient's needs, making it user-friendly and tailored.

What evidence suggests that CPAP is effective for reducing hypertensive disorders in pregnancy?

Research has shown that using a CPAP machine for pregnant women with sleep apnea might lower the risk of high blood pressure problems, such as gestational hypertension and preeclampsia. In this trial, participants may receive CPAP treatment, which studies have found could also lead to fewer early births and possibly healthier birth weights for babies. Although data remains limited, early results are promising. This suggests that CPAP could help manage sleep apnea and improve pregnancy outcomes. ^{2 4 6 7 8}

Who Is on the Research Team?

Rebecca Clifton, PhD

Principal Investigator

The George Washington University Biostatistics Center

Francesca Facco, MD

Principal Investigator

Magee Women's Hospital of UPMC

Monica Longo, MD

Principal Investigator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Are You a Good Fit for This Trial?

This trial is for pregnant women between 14 and nearly 22 weeks along, with a single baby, diagnosed with mild to moderate obstructive sleep apnea. Women must not have severe kidney disease, be on long-term steroids for asthma, use sleeping pills or oxygen therapy, or have certain other health conditions.

Inclusion Criteria

You must be between 14 weeks and 21 weeks pregnant based on a clinical evaluation and ultrasound.

Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.

I have been diagnosed with mild to moderate sleep apnea.

Exclusion Criteria

I am currently or will be treated for sleep apnea.

I need oxygen for a chronic lung condition and might not respond to CPAP therapy.

I have needed steroids for my asthma for more than 2 weeks in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive continuous positive airway pressure (CPAP) treatment during pregnancy

Throughout pregnancy

Weekly contact

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Positive Airway Pressure

Trial Overview The study tests if using CPAP (a machine that helps keep airways open) during pregnancy can lower the risk of high blood pressure disorders like preeclampsia compared to just getting sleep advice.

How Is the Trial Designed?

Group I: Sleep Advice Control Experimental Treatment 1 Intervention

Initial sleep advice counseling alone

Group II: Continuous Positive Airway Pressure Experimental Treatment 1 Intervention

Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling

Who Is Running the Clinical Trial?

The George Washington University Biostatistics Center

Lead Sponsor

Trials

27

Recruited

111,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Current screening tools for obstructive sleep apnea (OSA) may not be effective for pregnant women, highlighting a gap in diagnosis.

There is evidence suggesting that OSA in pregnant patients is associated with poorer maternal and neonatal outcomes, but there is currently insufficient data to determine the impact of treatment on these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis and treatment of obstructive sleep apnea during pregnancy. Abdullah, HR., Nagappa, M., Siddiqui, N., et al.[2018]

In a study of 177 pregnancies, women with obstructive sleep apnea (OSA) who were compliant with CPAP therapy showed a lower incidence of hypertensive disorders compared to those with untreated OSA, suggesting that CPAP may help reduce these risks.

The study found that 57% of women using CPAP experienced hypertensive complications, compared to 64% in the untreated OSA group and 43% in the control group, indicating a potential benefit of CPAP in managing hypertension during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure treatment of obstructive sleep apnea and hypertensive complications in high-risk pregnancy. Rice, AL., Bajaj, S., Wiedmer, AM., et al.[2023]

In a study of 16 pregnant women with hypertension, those using nasal CPAP alongside standard prenatal care experienced significantly better blood pressure control and required lower doses of antihypertensive medication compared to those receiving standard care alone.

The treatment group also had improved pregnancy outcomes, with all patients delivering healthy infants who had higher APGAR scores at one minute post-delivery, indicating better overall health at birth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-eclampsia and nasal CPAP: part 2. Hypertension during pregnancy, chronic snoring, and early nasal CPAP intervention. Poyares, D., Guilleminault, C., Hachul, H., et al.[2022]

Nasal continuous positive airway pressure (CPAP) is a safe and effective treatment for sleep disordered breathing (SDB) in pregnant women, as evidenced by full-term pregnancies and healthy infants in the study of 12 participants.

Compliance with CPAP improved over time, with an average usage of 6.5 hours per night at 6 months gestation, and significant reductions in sleepiness and fatigue were observed, indicating its positive impact on quality of life during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy, sleep disordered breathing and treatment with nasal continuous positive airway pressure. Guilleminault, C., Kreutzer, M., Chang, JL.[2019]

A 27-year-old pregnant woman developed severe obstructive sleep apnea during her sixth month of pregnancy, highlighting that pregnancy can trigger or worsen this condition.

The patient was effectively treated with nasal continuous positive airway pressure during pregnancy, but she continued to experience moderate obstructive sleep apnea after giving birth, indicating the need for ongoing management post-delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precipitation of obstructive sleep apnea during pregnancy. Kowall, J., Clark, G., Nino-Murcia, G., et al.[2009]

In a study involving 340 pregnant women with high-risk conditions and obstructive sleep apnea (OSA), continuous positive airway pressure (CPAP) treatment significantly reduced diastolic blood pressure (DBP) by an average of -2.2 mmHg, indicating its efficacy in managing blood pressure during pregnancy.

CPAP treatment also lowered the incidence of preeclampsia from 22.3% in the usual-care group to 13.1% in the CPAP group, suggesting that CPAP can be an effective intervention to reduce the risk of this serious condition in pregnant women with OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of obstructive sleep apnea in high risk pregnancy: a multicenter randomized controlled trial. Tantrakul, V., Ingsathit, A., Liamsombut, S., et al.[2023]

Obstructive sleep apnea (OSA) is likely underdiagnosed in pregnant women, especially as its prevalence may be increasing due to rising obesity rates, and it is linked to serious complications like hypertensive disorders and gestational diabetes.

Continuous positive airway pressure (CPAP) is the recommended treatment for OSA during pregnancy, showing both safety and good compliance, and early consultation with anesthesia is crucial for managing care during labor and delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripartum Management of Obstructive Sleep Apnea. Booth, JM., Tonidandel, AM.[2018]

In a study of 110 high-risk pregnant women, those with obstructive sleep apnea (OSA) who received continuous positive airway pressure (CPAP) treatment had a significantly lower incidence of severe hypertensive syndrome (8%) compared to those treated conservatively (24%).

CPAP treatment also improved night oxygen saturation levels and reduced daytime sleepiness, indicating its efficacy in managing OSA and associated complications during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of continuous positive airway pressure treatment on hypertensive disorder in pregnant women with obstructive sleep apnea. Stajić, D., Ilić, D., Vuković, J., et al.[2022]

CPAP therapy during pregnancy has shown positive effects, such as decreased blood pressure in women with hypertension or preeclampsia, and improved fetal outcomes like higher Apgar scores and increased fetal movements, based on a review of eight trials involving 90 pregnant women.

However, while CPAP did not improve glucose levels in women with gestational diabetes, it did increase insulin secretion, indicating a need for further research to establish clear guidelines for CPAP use in pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cardiovascular, metabolic, fetal and neonatal effects of CPAP use in pregnant women: a systematic review. Migueis, DP., Urel, A., Dos Santos, CC., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36866618/

The effectiveness of continuous positive airway pressure ... Treatment of OSA with CPAP in pregnancy may reduce hypertension and, preterm birth, and may increase neonatal birthweight.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822293

Continuous Positive Airway Pressure Treatment and ... These findings suggest that implementing CPAP treatment in pregnant women with OSA may reduce the risk of gestational hypertension and preeclampsia.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03487185

Continuous Positive Airway Pressure (CPAP) for Sleep ... Unfortunately, data on whether maternal and neonatal outcomes could be improved with treatment of OSA during pregnancy are extremely limited. This study aims to ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT03487185

Continuous Positive Airway Pressure (CPAP) for Sleep ... Unfortunately, data on whether maternal and neonatal outcomes could be improved with treatment of OSA during pregnancy are extremely limited.

5. researchprotocols.org researchprotocols.org/2025/1/e51434

Effect of Continuous Positive Airway Pressure or ... Objective: This study aims to determine the feasibility of conducting a randomized controlled trial to assess improved fetomaternal outcomes in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11322849/

Continuous Positive Airway Pressure Treatment and ... These findings suggest that implementing CPAP treatment in pregnant women with OSA may reduce the risk of adverse gestational hypertensive outcomes.

7. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/ajo.13654

The effectiveness of continuous positive airway pressure for ... Treatment of OSA with CPAP in pregnancy may reduce hypertension and, preterm birth, and may increase neonatal birthweight.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8889985/

The cardiovascular, metabolic, fetal and neonatal effects of ... None of the studies reported CPAP adverse effects in pregnant women or neonatal participants. Besides, it is a safe treatment with long term benefts for OSA ...