Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

Prospective, randomized controlled trial. Pregnant women in early pregnancy will be randomized to either the Sleep Study + CPAP (Continuous Positive Airway Pressure Therapy) group or to a Standard Prenatal Care group. Subjects in the Sleep Study + CPAP group will complete a sleep study (WatchPAT-200, Itamar Medical, Inc.) and have CPAP initiated if the Apnea Hypopnea Index (AHI) ≥5 as indicated, in early and late pregnancy, whereas the other group will receive standard prenatal care. All subjects will complete a sleep study again between 8 to 12 weeks postpartum.

Key facts

Study ID

NCT02755831

Run by

United States Naval Medical Center, San Diego

People needed

193

Starts

2017-02-20

Expected to finish

2019-10-14

Last updated by the study team

2019-11-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• At least one of the following risk factors for OSA: prepregnancy BMI ≥ 30kg/m2, chronic hypertension, pregestational diabetes, twin gestation, or a history of prior pregnancy affected by: preeclampsia, eclampsia or fetal growth restriction.
• Between 6 and 16 weeks gestation at time of enrollment.

You may not qualify if…

• Current diagnosis and treatment of OSA.
• Patient refusal to randomization.
• Permanent Pacemaker (interfere with WATCHPAT sleep study).
• Currently taking alpha blockers or nitrates (interfere with WATCHPAT sleep study).
• Coronary artery disease or congestive heart failure or cardiomyopathy.
• Not delivering and completing their postpartum visit at Naval Medical Center San Diego (NMCSD).
• Inability to read or understand the consent.
• <18 years of age.

Where it is running

• Naval Medical Center — San Diego, California, United States

Full record on ClinicalTrials.gov

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