Atomoxetine and Oxybutynin in Obstructive Sleep Apnea
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Obstructive Sleep Apnea (OSA)
In brief
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.
Key facts
- Study ID
- NCT02908529
- Run by
- Brigham and Women's Hospital
- People needed
- 22
- Starts
- 2016-09-01
- Expected to finish
- 2018-01-01
- Last updated by the study team
- 2019-01-29
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
Where it is running
- Sleep Disorders Research Program Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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