Phase 2
N=15
Role of Mirtazapine in Ameliorating Sleep Disordered Breathing
Spinal Cord Injuries · Sleep Disordered Breathing
Bottom Line
View on ClinicalTrials.gov: NCT04799782 ↗Enrolled (actual)
15
Serious AEs
4.0%
Results posted
Apr 2021
Primary outcome: Primary: CO2 Reserve (Delta-PETCO2-AT) — -3.8; -2.0 mmHg — p=0.015
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mirtazapine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wayne State University
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CO2 Reserve (Delta-PETCO2-AT) |
-3.8; -2.0 | 0.015 sig |
| SECONDARY AHI (Apnea/Hypopnea Index) |
46.4; 47.8 | 0.82 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04799782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.