- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02383706
Obstructive Sleep Apnea in Pregnancy (OSAinPreg)
Obstructive Sleep Apnea in Pregnancy: Development of a Pregnancy-Specific Screening Tool
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Subjects
Pregnant women, BMI greater than or equal to 40 undergo questionnaires, physical exam, and ApneaLink Air, at home, overnight polysomnography study.
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Overnight, home polysomnography device
OSA screening questionnaire
OSA screening questionnaire
OSA screening questionnaire
Physical exam of neck, mouth and upper airway
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With a Negative Obstructive Sleep Apnea (OSA) Home Sleep Test Result
Time Frame: Women studied at one time point between 24 weeks and 35 weeks gestation.
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Determined using the Apnea-Hypopnea Index (AHI).
Participants were considered OSA-negative if experienced less than five events per hour.
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Women studied at one time point between 24 weeks and 35 weeks gestation.
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Number of Participants With a Positive Obstructive Sleep Apnea (OSA) Home Sleep Test Result
Time Frame: Women studied at one time point between 24 weeks and 35 weeks gestation.
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Determined using the Apnea-Hypopnea Index (AHI).
Participants were considered OSA-positive if experienced five or more events per hour.
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Women studied at one time point between 24 weeks and 35 weeks gestation.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-op Minute Ventilation Following C-section
Time Frame: Women studied for 24-hours following their cesarean delivery.
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To evaluate post-operative minute ventilation in women who undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring
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Women studied for 24-hours following their cesarean delivery.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00056786
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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