Sleep-Disordered Breathing and PAP in Perinatal Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder; Sleep-disordered Breathing
• Interventions: Device: Positive Airway Pressure (PAP)

• Registration Number: NCT02507297
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-23
• Study Start: 2016-01
• Primary Completion: 2020-04-25
• Study Completion: 2020-04-25
• Results First Submitted: 2021-04-20
• Results First Submitted QC: 2021-04-20
• Results First Posted: 2021-05-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAP Group	Positive Airway Pressure (PAP)	Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly

Primary Outcome Measures

Name	Time	Method
Change in Hamilton Rating Scale for Depression (HRSD) Score, Minus the Sleep Item	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 Outcome Measures

Name	Time	Method
Change in Epworth Sleepiness Scale (ESS) Score	Baseline to 8 weeks after baseline, and at 12 weeks postpartum	Change in a measure of excessive daytime sleepiness. Scores range from 0 to 25. Higher scores indicate more daytime sleepiness.
Change in Salivary Cortisol	Baseline to 8 weeks after baseline	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.
Change in Edinburgh Postnatal Depression Scale Score	Baseline to 8 weeks after baseline, and at 12 weeks postpartum	Change in a self-report measure of depression symptoms and severity. Total scores range from 0 to 27; higher scores indicate more severe depression.
Change in Pittsburgh Sleep Quality Index Score	Baseline to 8 weeks after baseline, and at 12 weeks postpartum	Change in a measure of sleep quality. Total scores range from 0 to 21. Higher scores indicate worse sleep quality.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States