Phase 2 Completed N=11 Randomized Single-blind Basic Science

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

Spinal Cord Injury · sleep-disordered breathing

Source: ClinicalTrials.gov NCT02458469 ↗

Enrolled (actual)

Serious AEs

3.6%

Results posted

Apr 2020

Primary outcomePrimary: CO2 Reserve (Delta-PETCO2-AT) — -3.6; -2.5; -1.8 mmHg — p=0.019

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY CO2 Reserve (Delta-PETCO2-AT)	-3.6; -2.5; -1.8	0.019 sig
SECONDARY Apnea-Hypopnea Index (AHI)	48.7; 40.0; 45.2	0.749

Eligibility Criteria

Inclusion Criteria

Adults with SCI (>6months after spinal cord injury) at the T6 level/above

Exclusion Criteria

Pregnant and lactating females
Heart failure, vascular disease, or stroke
Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic kidney disease
BMI >38 kg/m2
Mechanical ventilation dependence
The following medications are not allowed (potential interaction with buspirone or inhibition of the CYP3A4 system):
cimetidine
ketoconazole
ritonavir
itraconazole
erythromycin
diltiazem
verapamil
Monoamine oxidase (MAO) inhibitors [such as Marplan, Nardil, Parmate, Emsam]
Other prohibited concomitant medications include haloperidol, trazodone, or triazolam

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Data sourced from ClinicalTrials.gov (NCT02458469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.