Sleep-Disordered Breathing and PAP in Perinatal Depression

Study Overview
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Brief Summary
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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.

Official Title
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Sleep-Disordered Breathing and PAP in Perinatal Depression

Conditions
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Sleep-disordered Breathing, Major Depressive Disorder

Intervention / Treatment
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* Device: Positive Airway Pressure (PAP)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAP Group<br>Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly | Device: Positive Airway Pressure (PAP)<br>* 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.<br>* Other names: CPAP;|
| No Intervention: TAU Group<br>Treatment as usual through obstetrics | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hamilton Rating Scale for Depression (HRSD) Score, Minus the Sleep Item | 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. | Baseline to 8 weeks after baseline, and at 12 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Edinburgh Postnatal Depression Scale Score | Change in a self-report measure of depression symptoms and severity. Total scores range from 0 to 27; higher scores indicate more severe depression. | Baseline to 8 weeks after baseline, and at 12 weeks postpartum | 
| Change in Pittsburgh Sleep Quality Index Score | Change in a measure of sleep quality. Total scores range from 0 to 21. Higher scores indicate worse sleep quality. | Baseline to 8 weeks after baseline, and at 12 weeks postpartum | 
| Change in Epworth Sleepiness Scale (ESS) Score | Change in a measure of excessive daytime sleepiness. Scores range from 0 to 25. Higher scores indicate more daytime sleepiness. | Baseline to 8 weeks after baseline, and at 12 weeks postpartum | 
| Change in Salivary Cortisol | Salivary cortisol is a hormone produced by the adrenal gland. Values are in nmol/L; detectable assay range is 0.33 - 82.77 nmol/L. Higher values indicate higher levels of cortisol. | Baseline to 8 weeks after baseline |