Skip to main content
OpenTrials
Completed

NCT Number: NCT02908529

Atomoxetine and Oxybutynin in Obstructive Sleep Apnea

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sleep Disorders Research Program Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combination product of Atomoxetine and Oxybutynin

Drug

Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 2 hours before sleep

Other names: Strattera + Ditropan

Placebo, 2 tablets

Drug

Placebo 2 tablets 2 hours before sleep

Primary outcomes

  1. Apnea Hypopnea Index (AHI, Events/Hour of Sleep)

    Time frame: 1 night

    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)

Secondary outcomes

  1. Genioglossus Muscle Responsiveness to Increased Ventilatory Drive (Esophageal Pressure Swings)

    Time frame: 1 night

    For genioglossus muscle responsiveness, data will be expressed as change in electromyography of genioglossus (GG EMG) for cmH2O change in esophageal pressure.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Effect of Atomoxetine and Oxybutynin on Phenotype Traits and OSA Severity

Acronym: ATOSA

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Sep 21, 2016
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.