NCT04799782

Role of Mirtazapine in Ameliorating Sleep Disordered Breathing

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Wayne State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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 taking Mirtazapine or placebo. After the one week treatment a sleep study will be repeated. Mirtazapine will be given at 15 mg dose before bed-time. (2) Cross over medication for one week will be followed by a second sleep study.

Conditions

• Spinal Cord Injuries
• Sleep Disordered Breathing

Interventions

Type	Name	Description
DRUG	Mirtazapine	15 mg dose before bed-time
DRUG	Placebo	One placebo pill before bed-time

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-05-18
• Completion: 2019-05-18
• First posted: 2021-03-16
• Last updated: 2021-06-15
• Results posted: 2021-04-20

Regulatory

• FDA-regulated drug study