Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy

Naval Medical Center

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: CPAP; Other: Pre-natal care

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02755831

NMCSD.2016.0029

Details and patient eligibility

About

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.

Full description

Objective/Hypothesis: The purpose of this study is to determine if parturients identified as high risk for obstructive sleep apnea (OSA; defined as an apnea hypopnea index [AHI] ≥5 events/hour) who are randomized to receive an unattended sleep study during early and late pregnancy (early = between 6 and 16 weeks; late = between 27 and 33 weeks) plus initiation of CPAP therapy if the AHI ≥5 events/hour and standard prenatal care have a decreased incidence of adverse pregnancy outcomes (defined as a composite variable which includes gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm birth, low birth weight, or stillbirth) at the time of delivery when compared to a group who receives standard prenatal care only (no sleep study and CPAP initiation). At 8 to 12 months postpartum subjects in both groups will complete a sleep study.

Enrollment: 193 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. 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.
2. Between 6 and 16 weeks gestation at time of enrollment.

Exclusion Criteria

1. Current diagnosis and treatment of OSA.
2. Patient refusal to randomization.
3. Permanent Pacemaker (interfere with WATCHPAT sleep study).
4. Currently taking alpha blockers or nitrates (interfere with WATCHPAT sleep study).
5. Coronary artery disease or congestive heart failure or cardiomyopathy.
6. Not delivering and completing their postpartum visit at Naval Medical Center San Diego (NMCSD).
7. Inability to read or understand the consent.
8. <18 years of age.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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193 participants in 2 patient groups

Sleep Study + CPAP group

Experimental group

Description:

Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment

Treatment:

Device: CPAP

Standard Prenatal Care group

Other group

Description:

Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.

Treatment:

Other: Pre-natal care