N/A
N=193
Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT02755831 ↗Enrolled (actual)
193
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Number of Participants With Adverse Pregnancy Outcomes — 45; 39 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CPAP (Device); Pre-natal care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- United States Naval Medical Center, San Diego
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Pregnancy Outcomes |
45; 39 | <0.05 sig |
| SECONDARY Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks) |
89; 3; 0; 1 | <.05 sig |
| SECONDARY Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks) |
81; 11; 0; 0 | <0.05 sig |
| SECONDARY Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group |
72; 69; 14; 9; 2; 2 | <0.05 sig |
| SECONDARY Hospital Costs at Time of Delivery |
12185; 12607 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02755831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.