Pathogenesis of Sleep Disordered Breathing in Spinal Cord Injury Patients
Phase: PHASE2
Conditions: Spinal Cord Injury, Sleep Disordered Breathing
Sponsor: VA Office of Research and Development

 
Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in 
Patients With SCI 
NCT02458469 
 
Abdulghani Sankari, MD, PhD 
3/12/2020 
 
 
 
 

Study Protocol: A pilot randomized placebo-controlled cross-over study. Eligible subjects with 
spinal cord injury were studied on three separate occasions: (1) Buspirone vs. Trazodone vs. 
placebo for 2 weeks; the participants were blinded to what medication they were taking. The 
initial dose of Buspirone is 15 mg daily (7.5 mg b.i.d.). Buspirone dosage was increased 5 mg 
per day at intervals of 2 to 3 days until a maximum dose of 30mg/day is reached. Trazodone 
was given at 100 mg dose before bed-time. After the two week treatment, a noninvasive nasal 
mechanical ventilation study was repeated to determine the hypocapnic apneic threshold. (2) 
Cross over medication for two weeks was followed by a second noninvasive nasal mechanical 
ventilation study to determine the hypocapnic apneic threshold followed by two weeks washout. 
(3) Cross over medication for two weeks was followed by another study to determine the 
hypocapnic apneic threshold. For the baseline hypocapnic apneic threshold the nasal 
mechanical ventilation study obtained from specific aim 1 was used as a baseline.  
Statistical Data analysis: The primary endpoint is the CO2 reserve (PETCO2–AT) which is a 
marker to measure susceptibility to hypocapnic central apnea, defined as the difference 
between average end-tidal CO2 (PETCO2) for the control breaths on room air and the breaths 
before the cessation of noninvasive nasal mechanical ventilation. The standard statistical 
package SPSS (Sigmstat, version 3.5) was used for data analysis.  A detailed descriptive 
analysis of all quantitative data was performed involving the summarization of data, and normal 
distribution. The primary analysis was repeated measure analysis of variance. In the absence of 
normal distribution of data, appropriate non-parametric tests were used.