At a glance
ClinicalIndex Comparison Record- ✓Apnea-Hypopnea Index (AHI) greater than 20
- ✕Any medical condition other than well-controlled hypertension
- ✕Any medication known to influence breathing, sleep/arousal, or muscle physiology
- ✕Claustrophobia
- ✕Unable to sleep supine
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Atomoxetine and Oxybutynin on Phenotype Traits and OSA Severity
In Brief
A Phase 2 clinical trial evaluating Combination product of Atomoxetine and Oxybutynin and Placebo, 2 tablets for Obstructive Sleep Apnea (OSA). Completed, enrolled 22 participants across 1 site.
Detailed Summary
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. Until recently, the search for medicines to activate pharyngeal muscles in sleeping humans has been discouraging. However, exciting new animal research has shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle activity to waking levels. In this protocol the investigators will test the effect of atomoxetine (a norepinephrine reuptake inhibitor) and oxybutynin (an antimuscarinic drug) administered together on OSA phenotype traits and OSA severity during sleep.
Study Details
Timeline
Interventions
Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 2 hours before sleep
Placebo 2 tablets 2 hours before sleep