Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: CPAP
* Other: Pre-natal care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Pregnancy Outcomes | 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) | 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) | 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 | 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 | Hospital costs at time of delivery in treatment and control group. | Hospital costs at time of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA, pregnancy, adverse pregnancy outcomes, continuous positive airway pressure, preeclampsia, gestational diabetes