Sleep-Disordered Breathing and PAP in Perinatal Depression



Status:Recruiting
Conditions:Depression, Depression, Insomnia Sleep Studies, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 45
Updated:9/27/2018
Start Date:January 2016
End Date:June 2020
Contact:Leslie Swanson, Ph.D.
Email:LMSwan@med.umich.edu
Phone:734-764-1234

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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.


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).
We found this trial at
1
site
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-232-1265
University of Michigan The University of Michigan was founded in 1817 as one of the...
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mi
from
Ann Arbor, MI
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