N/A
N=29
Sleep-Disordered Breathing and PAP in Perinatal Depression
Sleep-disordered Breathing · Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02507297 ↗Enrolled (actual)
29
Serious AEs
10.3%
Results posted
May 2021
Primary outcome: Primary: Change in Hamilton Rating Scale for Depression (HRSD) Score, Minus the Sleep Item — -7.62; -5.92; -8.21; -6.18 change in score — p=.367
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positive Airway Pressure (PAP) (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Michigan
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hamilton Rating Scale for Depression (HRSD) Score, Minus the Sleep Item |
-7.62; -5.92; -8.21; -6.18 | .367 |
| SECONDARY Change in Edinburgh Postnatal Depression Scale Score |
-4.13; -2.23; -3.00; -5.00 | .136 |
| SECONDARY Change in Pittsburgh Sleep Quality Index Score |
-1.64; -1.80; -1.29; -1.8 | .916 |
| SECONDARY Change in Epworth Sleepiness Scale (ESS) Score |
-2.14; -1.00; -2.14; -1 | .568 |
| SECONDARY Change in Salivary Cortisol |
-1.23; 1.38 | .486 |
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).
Data sourced from ClinicalTrials.gov (NCT02507297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.