Sleep-Disordered Breathing and PAP in Perinatal Depression

Major Depressive Disorder Clinical Trial

Official title:

Sleep-Disordered Breathing and PAP in Perinatal Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507297
• Other study ID #: 1K23HL122461-01A1
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: April 25, 2020

Study information

• Verified date: April 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 25, 2020
• Est. primary completion date: April 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep-disordered Breathing

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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