Sleep-Disordered Breathing and PAP in Perinatal Depression

NCT02507297 | Completed Results DMC

• 1 other identifier: 1K23HL122461-01A1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep-disordered Breathing; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Edinburgh Postnatal Depression Scale Score

  Baseline to 8 weeks after baseline, and at 12 weeks postpartum

• Change in Pittsburgh Sleep Quality Index Score

  Baseline to 8 weeks after baseline, and at 12 weeks postpartum

• Change in Epworth Sleepiness Scale (ESS) Score

  Baseline to 8 weeks after baseline, and at 12 weeks postpartum

• Change in Salivary Cortisol

  Baseline to 8 weeks after baseline

Study Arms (2)

PAP Group

EXPERIMENTAL

Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly

Device: Positive Airway Pressure (PAP)

TAU Group

NO INTERVENTION

Treatment as usual through obstetrics

Interventions

Positive Airway Pressure (PAP) DEVICE

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.

Also known as: CPAP

PAP Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Leslie Swanson
• Organization: University of Michigan

lmswan@umich.edu

734-764-2242

Study Officials

• Leslie Swanson, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 23, 2015
• Study Start: January 1, 2016
• Primary Completion: April 25, 2020
• Study Completion: April 25, 2020
• Last Updated: May 1, 2023
• Results First Posted: May 13, 2021

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)