Sleep-Disordered Breathing and PAP in Perinatal Depression

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 Overview

• Status: Completed
• Conditions: Major Depressive Disorder; Sleep-disordered Breathing
• Intervention / Treatment: Device: Positive Airway Pressure (PAP)

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Leslie Swanson, Ph.D., University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): April 25, 2020
• Study Completion (Actual): April 25, 2020

Study Registration Dates

• First Submitted: July 22, 2015
• First Submitted That Met QC Criteria: July 22, 2015
• First Posted (Estimate): July 23, 2015

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Mood Disorders; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Depressive Disorder; Sleep Apnea Syndromes; Respiratory Aspiration; Depressive Disorder, Major
• Other Study ID Numbers: 1K23HL122461-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO