drugset / Trial / NCT02458469

Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI

NCT02458469

Phase 2 Completed 15 enrolled VA Office of Research and Development
RandomizedCrossoverSingle-blindBasic science

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.

Timeline

Start
2015-05-14
Primary completion
2019-04-12
Completion
2019-04-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Buspirone Small molecule 30 mg
Comparator Trazodone Small molecule 100 mg