Clinical trial NCT02507297: Sleep-Disordered Breathing and PAP in Perinatal Depression
Official title: Sleep-Disordered Breathing and PAP in Perinatal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep-disordered Breathing
Major Depressive Disorder
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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).

Primary outcomes:
measure: Change in Hamilton Rating Scale for Depression (HRSD) Score, Minus the Sleep Item
timeFrame: Baseline to 8 weeks after baseline, and at 12 weeks postpartum
Secondary outcomes:
measure: Change in Edinburgh Postnatal Depression Scale Score
timeFrame: Baseline to 8 weeks after baseline, and at 12 weeks postpartum
measure: Change in Pittsburgh Sleep Quality Index Score
timeFrame: Baseline to 8 weeks after baseline, and at 12 weeks postpartum
measure: Change in Epworth Sleepiness Scale (ESS) Score
timeFrame: Baseline to 8 weeks after baseline, and at 12 weeks postpartum
measure: Change in Salivary Cortisol
timeFrame: Baseline to 8 weeks after baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Leslie Swanson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: