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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
29
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.
University of Michigan
Ann Arbor, Michigan, United States
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.
Time frame: Baseline to 8 weeks after baseline, and at 12 weeks postpartum
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 8 weeks after baseline
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