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NCT02507297 · ClinicalTrials.gov registry record · NA
Sleep-Disordered Breathing and PAP in Perinatal Depression
A NA study of Major Depressive Disorder and Sleep Disordered Breathing, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT02507297: Completed NA study of Major Depressive Disorder and Sleep Disordered Breathing, sponsored by University of Michigan.
NCT02507297 is a NA study of Major Depressive Disorder and Sleep Disordered Breathing that has completed, run by University of Michigan. The registered enrollment target is 29 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02507297, a NA study of Major Depressive Disorder and Sleep Disordered Breathing, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Positive Airway Pressure (PAP)
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2016-01 |
| Est. Completion | 2020-04-25 |
| Phase | NA |
What the finished NCT02507297 record still lists
NCT02507297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Positive Airway Pressure (PAP) is the first listed.
NCT02507297 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02507297 about?
NCT02507297 is a clinical study titled "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 sym...
What is the current status of trial NCT02507297?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2016-01. Estimated completion is 2020-04-25.
What conditions does trial NCT02507297 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Sleep Disordered Breathing.
What interventions are being tested in trial NCT02507297?
The interventions under investigation include: Positive Airway Pressure (PAP) (DEVICE).
Who is sponsoring clinical trial NCT02507297?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02507297 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02507297's enrollment target sits among peer trials
29 228th of 282 higher than 55 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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