Role of Mirtazapine in Ameliorating Sleep Disordered Breathing
Phase: PHASE2
Conditions: Spinal Cord Injuries, Sleep Disordered Breathing
Sponsor: Wayne State University

 
 
 
 
 
 
 
 
 
Role of Mirtazapine in Ameliorating Sleep Disordered Breathing 
 
NCT04799782 
Abdulghani Sankari, MD, PhD  
4/14/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol: Each subject will be studied on two separate occasions: (1) Mirtazapine vs. placebo 
for one week; the patients will be blinded to what medication they will be taking. The initial dose 
of Mirtazapine is 15 mg 30minutes before bed-time. After the one week treatment a noninvasive 
nasal mechanical ventilation study will be repeated to determine the hypocapnic apneic 
threshold. (2) Cross over medication for one week will be followed by a second noninvasive 
nasal mechanical ventilation study and PSG to determine the hypocapnic apneic threshold 
followed by two weeks washout. To assess the clinical effect of the drug on breathing during 
sleep a qualitative polysomnography will be performed for 2 hours the same night after taking 
the drug/placebo. This will allow the determination of ventilatory changes, calculation of upper 
airway resistance and the determination of the number of respiratory events (apnea/hypopnea 
index).