Atomoxetine and Oxybutynin in Obstructive Sleep Apnea (ATOSA)

Mass General Brigham

Status and phase

Completed

Phase 2

Phase 1

Conditions

Obstructive Sleep Apnea (OSA)

Treatments

Drug: Placebo, 2 tablets

Drug: Combination product of Atomoxetine and Oxybutynin

Study type

Interventional

Funder types

Other

Identifiers

NCT02908529

BWH-2014P001033

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criterion:

AHI > 20

Exclusion Criteria:

Any medical condition other than well controlled hypertension.
Any medication known to influence breathing, sleep/arousal or muscle physiology.
Claustrophobia.
Inability to sleep supine.
Allergy to lidocaine, Oxymetazoline HCl, atomoxetine/oxybutynin.
Individuals with underlying cardiac disease, such as arrhythmias.
Individuals taking psychiatric medications, such as atomoxetine, or any of the studied medications for medical care.
History of seizures
For women: Pregnancy.
History of panic disorder / hyperventilation syndrome / Attention deficit-hyperactivity disorder (ADHD) / autism