Atomoxetine and Oxybutynin in Obstructive Sleep Apnea

Obstructive Sleep Apnea (OSA) Clinical Trial

— ATOSA  

Official title:

Effect of Atomoxetine and Oxybutynin on Phenotype Traits and OSA Severity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908529
• Other study ID #: BWH-2014P001033
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Combination product of Atomoxetine and Oxybutynin
Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 2 hours before sleep
• Placebo, 2 tablets
Placebo 2 tablets 2 hours before sleep

Locations

Country	Name	City	State
United States	Sleep Disorders Research Program Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index (AHI, Events/Hour of Sleep)	Based on previous studies the investigators anticipate that Atomoxetine and Oxybutynin will reduce AHI more effectively in subjects with moderate sleep apnea, mildly obese (BMI<32), Vpassive > 50% of Veupnea (ventilation during eupneic ventilatory drive), low muscle compensation (Vactive - Vpassive <1 L/min)	1 night
Secondary	Genioglossus Muscle Responsiveness to Increased Ventilatory Drive (Esophageal Pressure Swings)	For genioglossus muscle responsiveness, data will be expressed as change in electromyography of genioglossus (GG EMG) for cmH2O change in esophageal pressure.	1 night