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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 May 2023 |
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Main ID: |
NCT02507297 |
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Date of registration:
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22/07/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sleep-Disordered Breathing and PAP in Perinatal Depression
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Scientific title:
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Sleep-Disordered Breathing and PAP in Perinatal Depression |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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29 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02507297 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Leslie Swanson, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Michigan |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Sleep-disordered Breathing
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Major Depressive Disorder
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Intervention(s)
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Device: Positive Airway Pressure (PAP)
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Change in Pittsburgh Sleep Quality Index Score
[Time Frame: Baseline to 8 weeks after baseline, and at 12 weeks postpartum]
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Change in Edinburgh Postnatal Depression Scale Score
[Time Frame: Baseline to 8 weeks after baseline, and at 12 weeks postpartum]
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Change in Epworth Sleepiness Scale (ESS) Score
[Time Frame: Baseline to 8 weeks after baseline, and at 12 weeks postpartum]
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Change in Salivary Cortisol
[Time Frame: Baseline to 8 weeks after baseline]
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Secondary ID(s)
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1K23HL122461-01A1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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