NCT02507297

Sleep-Disordered Breathing and PAP in Perinatal Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep-disordered Breathing
• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Positive Airway Pressure (PAP)	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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2020-04-25
• Completion: 2020-04-25
• First posted: 2015-07-23
• Last updated: 2023-05-01
• Results posted: 2021-05-13

Locations

1 site across 1 country: United States