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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02908529
Other study ID # BWH-2014P001033
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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