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NCT Number: NCT02507297

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.

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Key information

Conditions

Sleep-Disordered Breathing Apnea Depressive Disorder Depressive Disorder, Major Dyssomnias Major Depressive Disorder Mental Disorders Mood Disorders Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: CPAP

Primary outcomes

  1. Change in Hamilton Rating Scale for Depression (HRSD) Score, Minus the Sleep Item

    Time frame: 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 outcomes

  1. Change in Edinburgh Postnatal Depression Scale Score

    Time frame: 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.

  2. Change in Pittsburgh Sleep Quality Index Score

    Time frame: 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.

  3. Change in Epworth Sleepiness Scale (ESS) Score

    Time frame: 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.

  4. Change in Salivary Cortisol

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 23, 2015
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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