Phase 2
N=22
Atomoxetine and Oxybutynin in Obstructive Sleep Apnea
Obstructive Sleep Apnea (OSA)
Bottom Line
View on ClinicalTrials.gov: NCT02908529 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Apnea Hypopnea Index (AHI, Events/Hour of Sleep) — 28.5; 7.5 events/hours of sleep — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Combination product of Atomoxetine and Oxybutynin (Drug); Placebo, 2 tablets (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea Hypopnea Index (AHI, Events/Hour of Sleep) |
28.5; 7.5 | <0.001 sig |
| SECONDARY Genioglossus Muscle Responsiveness to Increased Ventilatory Drive (Esophageal Pressure Swings) |
2.2; 6.3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02908529). 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.