Obstructive Sleep Apnea in Pregnancy

NCT ID: NCT02383706

Last Updated: 2019-06-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-08-31

Brief Summary

Obstructive sleep apnea (OSA) is a risk factor for complications during pregnancy and current screening tools for OSA have not been shown to be reliable in pregnant women. The primary aim of this study is to develop a valid screening tool to identify at-risk pregnant women, so that they can be further evaluated and treated. Women with OSA may also be at risk for respiratory complications related to opiate administration for post-cesarean delivery pain. A secondary aim of this study is to evaluate post-operative minute ventilation in women who undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring.

Detailed Description

Following recruitment and informed consent, subjects will complete 3 screening questionnaires for OSA: the Berlin and STOP-BANG questionnaires, and the Epworth Sleepiness Scale. They will also undergo a physical exam by one of the study investigators including examination of the neck and upper airway to assess neck circumference, retrognathia, thyromental space, tongue scalloping, MMS, modified MMS, tonsil size and lateral pharyngeal wall narrowing.

Subjects will all receive ApneaLink™ Air (ResMed, Poway, CA), a FDA-approved, non-invasive, portable, home polysomnography device, and instructions for using the device during one night of sleep. They will be given contact information if they have questions regarding use of the device. Subjects will receive a prepaid FedEx envelope to return the device. They will receive a parking voucher worth up to a maximum of $7 during this appointment. Subjects will be compensated ($50 check by mail) once the device is received. A follow-up phone call will be made by the PI to inform the subject of the results of the home polysomnography study. Subjects who screen positive (AHI > 5) by home polysomnography will be referred to Duke Sleep Medicine for further evaluation. Pregnancy outcomes will be followed for all subjects.

Enrolled subjects who go on to have a cesarean delivery will be studied using ExSpiron (Respiratory Motion, Inc., Waltham, MA), a FDA-approved, non-invasive respiratory volume monitor for 24 hours. The monitor has three adhesive pads that attach to the chest wall and a cord that attaches to the monitoring device, similar to an electrocardiogram. The monitor can be detached and the study suspended when patients ambulate to the restroom, and should not interfere with breastfeeding. The monitor will be connected to the patient in the pre-operative holding area, and the monitor will be calibrated with baseline spirometry measurements using a Wright spirometer over one minute. The subject will wear the device for the duration of the surgery, in the recovery room, and for 24 following surgery. The non-invasive respiratory volume monitor will be collected by study personnel at the conclusion of the 24 hours, and no data collected from the monitor will be used for clinical decision-making. Standard of care will be followed for the antepartum, intrapartum and postpartum management of those patients. Patients will continue to be monitored using the investigators' standard protocol for patients who have received neuraxial morphine which consists of continuous monitoring for 2 hours, followed by monitoring every 2 hours for 24 hours of the following: vital signs, oxygen saturation, respiratory rate, pain score and sedation score. The investigators also have nursing standing orders for naloxone administration for respiratory rate < 8 breaths/min or Richmond Agitation Sedation Scale (RASS) ≤ -3, together with immediate notification of medical staff, as well an order to notify medical staff for oxygen saturation < 90% or RASS < -2.

Conditions

Sleep Apnea, Obstructive; Pregnancy; Obesity, Morbid

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects

Pregnant women, BMI greater than or equal to 40 undergo questionnaires, physical exam, and ApneaLink Air, at home, overnight polysomnography study.

ApneaLink Air

Intervention Type: DEVICE

Overnight, home polysomnography device

Berlin Quesionnaire

Intervention Type: BEHAVIORAL

OSA screening questionnaire

Epworth Sleepiness Scale

Intervention Type: BEHAVIORAL

OSA screening questionnaire

STOP-BANG questionnaire

Intervention Type: BEHAVIORAL

OSA screening questionnaire

Physical exam

Intervention Type: OTHER

Physical exam of neck, mouth and upper airway

Interventions

ApneaLink Air

Overnight, home polysomnography device

Intervention Type: DEVICE

Berlin Quesionnaire

OSA screening questionnaire

Intervention Type: BEHAVIORAL

Epworth Sleepiness Scale

OSA screening questionnaire

Intervention Type: BEHAVIORAL

STOP-BANG questionnaire

OSA screening questionnaire

Intervention Type: BEHAVIORAL

Physical exam

Physical exam of neck, mouth and upper airway

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• gestational age 24 to 35 weeks
• BMI > or equal to 40 kg/m2
• 18 years or older

Exclusion Criteria

• Non-English speaking subjects
• Established diagnosis of OSA
• chronic narcotic use

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

Dominguez JE, Grotegut CA, Cooter M, Krystal AD, Habib AS. Screening extremely obese pregnant women for obstructive sleep apnea. Am J Obstet Gynecol. 2018 Dec;219(6):613.e1-613.e10. doi: 10.1016/j.ajog.2018.09.001. Epub 2018 Sep 11.

Reference Type: DERIVED

PMID: 30217579 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00056786

Identifier Type: -

Identifier Source: org_study_id