Role of Mirtazapine in Ameliorating Sleep Disordered Breathing

• Status: Completed
• Trial end date: 2019-05-18
• Target enrollment: 0
• Participant gender: All

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 with spinal cord injury (SCI) and non-injured persons during sleep. During this part of the study participants will be asked to take Mirtazapine (15mg per day) and a placebo in a random fashion, each for a one week period (drug period) of time followed by one week without drugs (washout period). The drugs will not be taken all at the same time, but each will be taken separately for one weeks followed by a night study to look at the effect the Mirtazapine/placebo pill has on the way the body responds during sleep.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wayne State University
• Treatments: Mirtazapine

Criteria

Inclusion Criteria:

• Adults with SCI (>6months after spinal cord injury) at the T6 level/above

• Non-injured adults

Exclusion Criteria:

• 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