Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy

November 25, 2019 updated by: CAPT Dennis Spence, NC, USN, PhD, CRNA, United States Naval Medical Center, San Diego

Randomized Controlled Trial for a Sleep Study and Targeted CPAP Therapy for Obstructive Sleep Apnea to Reduce the Incidence Adverse Pregnancy Related Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92134
        • Naval Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sleep Study + CPAP group
Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment
Device: CPAP
Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea
Other: Standard Prenatal Care group
Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.
Other: Pre-natal care
Standard Pre-Natal Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Pregnancy Outcomes
Time Frame: time of delivery
Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth)
time of delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks)
Time Frame: early pregnancy (6-16 weeks)
Incidence of OSA severity in early pregnancy (6-16 weeks) in treatment group only. Data were not collected for Control group at this time point.
early pregnancy (6-16 weeks)
Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks)
Time Frame: 27-33 weeks
Incidence and severity of OSA in late pregnancy- treatment group only (27-33 weeks). Data were not collected for Control group at this time point
27-33 weeks
Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group
Time Frame: 8-12 weeks postpartum
Incidence and severity of OSA at 8 to 12 weeks postpartum in treatment and control group.
8-12 weeks postpartum
Hospital Costs at Time of Delivery
Time Frame: Hospital costs at time of delivery
Hospital costs at time of delivery in treatment and control group.
Hospital costs at time of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Naval Medical Center, San Diego

Investigators

  • Study Director: Dennis L Spence, PhD, United States Naval Medical Center, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2017

Primary Completion (Actual)

October 14, 2019

Study Completion (Actual)

October 14, 2019

Study Registration Dates

First Submitted

March 11, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Actual)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMCSD.2016.0029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan to submit manuscripts to appropriate journals and present data at appropriate conferences

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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