Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755831
• Other study ID #: NMCSD.2016.0029
• Status: Completed
• Phase: N/A
• Start date: February 20, 2017
• Est. completion date: October 14, 2019

Study information

• Verified date: November 2019
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: October 14, 2019
• Est. primary completion date: October 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Other:
• Pre-natal care
Standard Pre-Natal Care

Locations

Country	Name	City	State
United States	Naval Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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
Secondary	Hospital Costs at Time of Delivery	Hospital costs at time of delivery in treatment and control group.	Hospital costs at time of delivery