NCT02908529

Atomoxetine and Oxybutynin in Obstructive Sleep Apnea

Effect of Atomoxetine and Oxybutynin on Phenotype Traits and OSA Severity

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea (OSA)

Interventions

Type	Name	Description
DRUG	Combination product of Atomoxetine and Oxybutynin	Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 2 hours before sleep
DRUG	Placebo, 2 tablets	Placebo 2 tablets 2 hours before sleep

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-12-01
• Completion: 2018-01-01
• First posted: 2016-09-21
• Last updated: 2019-01-29
• Results posted: 2019-01-29

Locations

1 site across 1 country: United States