Sleep-Disordered Breathing and PAP in Perinatal Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Change in Hamilton Rating Scale for Depression (HRSD) Score, Minus the Sleep Item
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
PAP Group
Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly
Intervention: Positive Airway Pressure (PAP) (Device)
TAU Group
Treatment as usual through obstetrics
Outcomes
Primary Outcomes
Change in Hamilton Rating Scale for Depression (HRSD) Score, Minus the Sleep Item
Time Frame: Baseline to 8 weeks after baseline, and at 12 weeks postpartum
Change in clinician-rated depression severity and symptoms, excluding the items which measure sleep. Total score range: 0-46. Higher scores represent more severe depression.
Secondary Outcomes
- Change in Epworth Sleepiness Scale (ESS) Score(Baseline to 8 weeks after baseline, and at 12 weeks postpartum)
- Change in Salivary Cortisol(Baseline to 8 weeks after baseline)
- Change in Edinburgh Postnatal Depression Scale Score(Baseline to 8 weeks after baseline, and at 12 weeks postpartum)
- Change in Pittsburgh Sleep Quality Index Score(Baseline to 8 weeks after baseline, and at 12 weeks postpartum)
Investigators
Leslie Swanson
Clinical Assistant Professor
University of Michigan