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Sleep-Disordered Breathing and PAP in Perinatal Depression

Primary Purpose

Sleep-disordered Breathing, Major Depressive Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Positive Airway Pressure (PAP)

About this trial

This is an interventional treatment trial for Sleep-disordered Breathing

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PAP Group

TAU Group

Arm Description

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

Treatment as usual through obstetrics

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT02507297

First Posted

July 22, 2015

Last Updated

April 26, 2023

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT02507297

Brief Title

Sleep-Disordered Breathing and PAP in Perinatal Depression

Official Title

Sleep-Disordered Breathing and PAP in Perinatal Depression

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

April 25, 2020 (Actual)

Study Completion Date

April 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep-disordered Breathing, Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PAP Group

Arm Type

Experimental

Arm Description

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

Arm Title

TAU Group

Arm Type

No Intervention

Arm Description

Treatment as usual through obstetrics

Intervention Type

Device

Intervention Name(s)

Positive Airway Pressure (PAP)

Other Intervention Name(s)

CPAP

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in Edinburgh Postnatal Depression Scale Score

Description

Change in a self-report measure of depression symptoms and severity. Total scores range from 0 to 27; higher scores indicate more severe depression.

Time Frame

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

Title

Change in Pittsburgh Sleep Quality Index Score

Description

Change in a measure of sleep quality. Total scores range from 0 to 21. Higher scores indicate worse sleep quality.

Time Frame

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

Title

Change in Epworth Sleepiness Scale (ESS) Score

Description

Change in a measure of excessive daytime sleepiness. Scores range from 0 to 25. Higher scores indicate more daytime sleepiness.

Time Frame

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

Title

Change in Salivary Cortisol

Description

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.

Time Frame

Baseline to 8 weeks after baseline

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leslie Swanson, Ph.D.

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Sleep-Disordered Breathing and PAP in Perinatal Depression

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