Ann Arbor, Michigan 48109


Purpose:

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.


Criteria:

Inclusion Criteria: - 20-32 weeks gestation with a single, live fetus - meet criteria for major depressive disorder per the Structured Clinical Interview for DSM-V (SCID) - respiratory distress index (RDI; includes apneas, hypopneas, and respiratory effort-related arousals)≥5 per ambulatory assessment plus apnea symptoms (snoring, witnessed apnea, daytime sleepiness, sleep disturbance, snort arousals) - stable dose (for ≥8 weeks) of a selective serotonin reuptake inhibitor (SSRI) OR free of all antidepressant medications past 4 weeks - obstetrics care is at the University of Michigan, and the woman plans on delivering her baby at the University of Michigan Exclusion Criteria: - Diagnosis of bipolar disorder, posttraumatic stress disorder, schizophrenia or psychosis, dissociative disorders, eating disorder, obsessive-compulsive disorder, somatic symptom and related disorders, substance use disorder, panic disorder, agoraphobia per DSM-V - diagnosis of, or suspicion for, narcolepsy or REM behavior disorder - current SDB treatment; medical conditions for which PAP is contraindicated (e.g., pneumothorax, pneumocephalus, recent trauma, recent surgery) - evidence of risk for drowsy driving (excessive daytime sleepiness plus history of motor vehicle accident or near miss due to sleepiness, fatigue, or inattention in past 12 months).


NCT ID:

NCT02507297


Primary Contact:

Principal Investigator
Leslie Swanson, Ph.D.
University of Michigan

Leslie Swanson, Ph.D.
Phone: 734-764-1234
Email: LMSwan@med.umich.edu


Backup Contact:

N/A


Location Contact:

Ann Arbor, Michigan 48109
United States

Jennifer Zollars
Phone: 734-232-1265
Email: wolfejk@med.umich.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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