Status:
COMPLETED
Role of Mirtazapine in Ameliorating Sleep Disordered Breathing
Lead Sponsor:
Wayne State University
Conditions:
Spinal Cord Injuries
Sleep Disordered Breathing
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to look at the effect of using Mirtazapine to target a specific pathway in the body, that relies on a natural chemical the body produces called 'serotonin', in patients wi...
Detailed Description
Randomized placebo controlled cross-over study. Each subject will be studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; the participants will be blinded to whether they are t...
Eligibility Criteria
Inclusion
- Adults with SCI (\>6months after spinal cord injury) at the T6 level/above
- Non-injured adults
Exclusion
- Pregnant and lactating females
- Heart failure, vascular disease, or stroke
- Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic kidney disease
- BMI \>38 kg/m2
- Mechanical ventilation dependence
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04799782
Start Date
January 1 2017
End Date
May 18 2019
Last Update
June 15 2021
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