CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 242 enrolled
Drug / intervention
CPAP +2 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/NCT02086448
NCT02086448N/ACompleted
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Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP)

Francesca Facco, MD·interventional·Posted Mar 13, 2014·Updated Mar 22, 2023

In Brief

A clinical study evaluating CPAP, sham-CPAP, and 1 other intervention for Obese and 2 related conditions. Completed, enrolled 242 participants across 1 site.

Detailed Summary

The purpose of this study is to better understand how sleep apnea, a common sleep disorder in which a person has one or more pauses in breathing or shallow breaths while sleeping, may affect pregnancy and to determine the effect of Continuous Positive Airway Pressure (CPAP), a treatment that uses mild air pressure to keep the airways open during sleep, for pregnant women with sleep apnea.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObese, Pregnancy, Sleep Disordered Breathing
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 13, 2014
Enrollment StartSep 1, 2014
Primary CompletionDec 1, 2021
Study CompletionFeb 1, 2022
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 12.3 years ago

Interventions

CPAPdevice

CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).

sham-CPAPdevice

Sleep hygieneother

Information about sleep apnea and healthy sleep. Information about local sleep resources