Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy

NCT ID: NCT02755831

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-20
• Study Completion Date: 2019-10-14

Brief Summary

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.

Detailed 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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sleep Study + CPAP group

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

Group Type: EXPERIMENTAL

CPAP

Intervention Type: DEVICE

Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea

Standard Prenatal Care group

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

Group Type: OTHER

Pre-natal care

Intervention Type: OTHER

Standard Pre-Natal Care

Interventions

CPAP

Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea

Intervention Type: DEVICE

Pre-natal care

Standard Pre-Natal Care

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

United States Naval Medical Center, San Diego

FED

Sponsor Role: lead

Responsible Party

CAPT Dennis Spence, NC, USN, PhD, CRNA

Anesthesia Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis L Spence, PhD

Role: STUDY_DIRECTOR

United States Naval Medical Center, San Diego

Locations

Naval Medical Center

San Diego, California, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NMCSD.2016.0029

Identifier Type: -

Identifier Source: org_study_id