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Obstructive Sleep Apnea in Pregnancy

Obstructive Sleep Apnea in Pregnancy: Development of a Pregnancy-Specific Screening Tool

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02383706
Acronym
OSAinPreg
Enrollment
108
Registered
2015-03-09
Start date
2015-02-28
Completion date
2017-08-31
Last updated
2019-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Obstructive, Pregnancy, Obesity, Morbid

Keywords

Sleep Apnea, Obstructive, Pregnancy, Obesity, Morbid, Complications, pregnancy

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.

Interventions

Overnight, home polysomnography device

BEHAVIORALBerlin Quesionnaire

OSA screening questionnaire

OSA screening questionnaire

OSA screening questionnaire

Physical exam of neck, mouth and upper airway

Sponsors

Duke University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With a Negative Obstructive Sleep Apnea (OSA) Home Sleep Test ResultWomen studied at one time point between 24 weeks and 35 weeks gestation.Determined using the Apnea-Hypopnea Index (AHI). Participants were considered OSA-negative if experienced less than five events per hour.
Number of Participants With a Positive Obstructive Sleep Apnea (OSA) Home Sleep Test ResultWomen studied at one time point between 24 weeks and 35 weeks gestation.Determined using the Apnea-Hypopnea Index (AHI). Participants were considered OSA-positive if experienced five or more events per hour.

Secondary

MeasureTime frameDescription
Post-op Minute Ventilation Following C-sectionWomen studied for 24-hours following their cesarean delivery.To evaluate post-operative minute ventilation in women who undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring

Countries

United States

Participant flow

Participants by arm

ArmCount
Subjects
Pregnant women, BMI greater than or equal to 40 undergo questionnaires, physical exam, and ApneaLink Air, at home, overnight polysomnography study. ApneaLink Air: Overnight, home polysomnography device Berlin Quesionnaire: OSA screening questionnaire Epworth Sleepiness Scale: OSA screening questionnaire STOP-BANG questionnaire: OSA screening questionnaire Physical exam: Physical exam of neck, mouth and upper airway
80
Total80

Baseline characteristics

CharacteristicSubjects
Age, Continuous
All subjects
29.5 years
Age, Continuous
No Obstructive Sleep Apnea
27 years
Age, Continuous
Obstructive Sleep Apnea
33 years
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
78 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Pre-pregnancy Body Mass Index (BMI)
All subjects
46 kg/m^2
Pre-pregnancy Body Mass Index (BMI)
No Obstructive Sleep Apnea
45 kg/m^2
Pre-pregnancy Body Mass Index (BMI)
Obstructive Sleep Apnea
53 kg/m^2
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
52 Participants
Race (NIH/OMB)
More than one race
4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
Race (NIH/OMB)
White
20 Participants
Region of Enrollment
United States
80 Participants
Sex: Female, Male
Female
80 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 108
other
Total, other adverse events
0 / 108
serious
Total, serious adverse events
0 / 108

Outcome results

Primary

Number of Participants With a Negative Obstructive Sleep Apnea (OSA) Home Sleep Test Result

Determined using the Apnea-Hypopnea Index (AHI). Participants were considered OSA-negative if experienced less than five events per hour.

Time frame: Women studied at one time point between 24 weeks and 35 weeks gestation.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SubjectsNumber of Participants With a Negative Obstructive Sleep Apnea (OSA) Home Sleep Test Result61 Participants
Primary

Number of Participants With a Positive Obstructive Sleep Apnea (OSA) Home Sleep Test Result

Determined using the Apnea-Hypopnea Index (AHI). Participants were considered OSA-positive if experienced five or more events per hour.

Time frame: Women studied at one time point between 24 weeks and 35 weeks gestation.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SubjectsNumber of Participants With a Positive Obstructive Sleep Apnea (OSA) Home Sleep Test Result19 Participants
Secondary

Post-op Minute Ventilation Following C-section

To evaluate post-operative minute ventilation in women who undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring

Time frame: Women studied for 24-hours following their cesarean delivery.

Population: Data not collected

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026