Clinical trial NCT04799782
Conditions: Spinal Cord Injuries Sleep Disordered Breathing
Sponsor: Wayne State University
Start date: 2017-01-01; Completion date: 2019-05-18
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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 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.

Arms: arm 1: The drug will be taken for a one week peroid. arm 2: The drug will be taken for a one week peroid.
Interventions: intervention 1: Mirtazapine intervention 2: Placebo
Intervention descriptions: intervention 1: 15 mg dose before bed-time intervention 2: One placebo pill before bed-time

Protocol documents:
Prot_000.pdf: 
 
 
 
 
 
 
 
 
 
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).  

SAP_001.pdf: 
 
 
 
 
 
 
 
 
 
Role of Mirtazapine in Ameliorating Sleep Disordered Breathing 
 
NCT04799782 
Abdulghani Sankari, MD, PhD  
4/14/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 


Statistical Analysis: Demographic characteristics (age, gender, BMI and level of SCI injury) are 
summarized as mean and standard deviation (SD) or frequency and percentage scores, as 
applicable. A paired-samples t-test is used to examine the change in CO2 reserve (primary 
outcome), CG, plant gain (PG), as well as SDB and ventilatory parameters (secondary 
outcomes) between the two treatment groups (Mirtazapine vs. placebo). The SDB parameter 
include apnea-hypopnea index, sleep staging and timing, oxygen desaturation index and 
arousal index. The ventilatory parameters include tidal volume, frequency and minute 
ventilation. All analyses are considered as statistically significant at p≤ 0.05.