At a glance
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Pathogenesis of Sleep Disordered Breathing in Spinal Cord Injury Patients
In Brief
A Phase 2 clinical trial evaluating Buspirone, Trazodone, and 1 other intervention for Spinal Cord Injury and Sleep Disordered Breathing. Completed, enrolled 15 participants across 1 site.
Detailed Summary
The purpose of this study is to look at the effect of exciting using drugs 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) during sleep. During this part of the study participants will be asked to take buspirone (Buspar) (15-50mg per day), trazodone (100mg per day) and a placebo in a random fashion, each for a 2 week period (drug period) of time followed by two weeks without drugs (washout period). The drugs will not be taken all at the same time, but each will be taken separately for two weeks followed by a night study to look at the effect the medication/placebo pill has on the way the body responds during sleep.
Study Details
Timeline
Interventions
The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached.
100 mg dose before bed-time
One placebo pill before bed-time