CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
Positive Airway Pressure (PAP)device
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/NCT02507297
NCT02507297N/ACompleted

Sleep-Disordered Breathing and PAP in Perinatal Depression

University of Michigan·interventional·Posted Jul 23, 2015·Updated May 1, 2023

In Brief

A clinical study evaluating Positive Airway Pressure (PAP) for Sleep-disordered Breathing and Major Depressive Disorder. Completed, enrolled 29 participants across 1 site.

Detailed Summary

The goal of this study is to understand the contribution of sleep-disordered breathing (SDB) to one of the most common and debilitating adverse pregnancy outcomes, perinatal depression. The study is a randomized trial to test the efficacy of positive airway pressure (PAP) on sleep and depression symptoms in perinatal women. Participants will be pregnant women with depression and sleep-disordered breathing. Participants will be randomly assigned to receive either PAP therapy (PAP group) or treatment as usual within obstetrics (TAU group). Mood and sleep assessments will be completed at baseline, after 1 week of enrollment, and monthly thereafter through 12 weeks postpartum. Cortisol will be measured using saliva collection at baseline and again 8 weeks later.

Study Details

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

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 23, 2015
Enrollment StartJan 1, 2016
Primary CompletionApr 25, 2020
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 10.9 years ago

Interventions

Positive Airway Pressure (PAP)device

Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device.