Back to resultsTargeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP
Pre-natal care
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring OSA, pregnancy, adverse pregnancy outcomes, continuous positive airway pressure, preeclampsia, gestational diabetes
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.
Sites / Locations
- Naval Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Sleep Study + CPAP group
Standard Prenatal Care group
Arm Description
Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment
Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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
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.
Hospital Costs at Time of Delivery
Hospital costs at time of delivery in treatment and control group.
Full Information
NCT ID
NCT02755831
First Posted
March 11, 2016
Last Updated
November 25, 2019
Sponsor
United States Naval Medical Center, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT02755831
Brief Title
Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy
Official Title
Randomized Controlled Trial for a Sleep Study and Targeted CPAP Therapy for Obstructive Sleep Apnea to Reduce the Incidence Adverse Pregnancy Related Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 20, 2017 (Actual)
Primary Completion Date
October 14, 2019 (Actual)
Study Completion Date
October 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Naval Medical Center, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
OSA, pregnancy, adverse pregnancy outcomes, continuous positive airway pressure, preeclampsia, gestational diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
193 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleep Study + CPAP group
Arm Type
Experimental
Arm Description
Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment
Arm Title
Standard Prenatal Care group
Arm Type
Other
Arm Description
Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea
Intervention Type
Other
Intervention Name(s)
Pre-natal care
Intervention Description
Standard Pre-Natal Care
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Pregnancy Outcomes
Description
Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth)
Time Frame
time of delivery
Secondary Outcome Measure Information:
Title
Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks)
Description
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.
Time Frame
early pregnancy (6-16 weeks)
Title
Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks)
Description
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
Time Frame
27-33 weeks
Title
Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group
Description
Incidence and severity of OSA at 8 to 12 weeks postpartum in treatment and control group.
Time Frame
8-12 weeks postpartum
Title
Hospital Costs at Time of Delivery
Description
Hospital costs at time of delivery in treatment and control group.
Time Frame
Hospital costs at time of delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis L Spence, PhD
Organizational Affiliation
United States Naval Medical Center, San Diego
Official's Role
Study Director
Facility Information:
Facility Name
Naval Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Plan to submit manuscripts to appropriate journals and present data at appropriate conferences
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Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy
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