CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 108 enrolled
Drug / intervention
ApneaLink Air +4 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02383706
NCT02383706N/ACompleted

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

Duke University·observational·Posted Mar 9, 2015·Updated Jun 19, 2019

In Brief

An observational study evaluating ApneaLink Air, Berlin Quesionnaire, and 3 other interventions for Sleep Apnea, Obstructive and 2 related conditions. Completed, enrolled 108 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 9, 2015
Enrollment StartFeb 1, 2015
Primary CompletionMay 1, 2017
Study CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.3 years ago

Interventions

ApneaLink Airdevice

Overnight, home polysomnography device

Berlin Quesionnairebehavioral

OSA screening questionnaire

Epworth Sleepiness Scalebehavioral

OSA screening questionnaire

STOP-BANG questionnairebehavioral

OSA screening questionnaire

Physical examother

Physical exam of neck, mouth and upper airway