NCT02109731

Upper Airway Physical Therapy for the Treatment of Obstructive Sleep Apnea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effectiveness and feasibility of upper airway muscle physical therapy utilizing negative airway pressure (NAP) breathing training in patients with Obstructive Sleep Apnea Syndrome (OSAS) in reducing both signs (apnea hypopnea index) and symptoms (i.e., daytime sleepiness).The key to the proposed therapy is the use of Negative Air Pressure when awake so that the increased reflex phasic drive to the muscles will result in muscle conditioning. Interestingly, other studies have indicated that upper airway muscle training may be useful in treating OSAS, but these studies used techniques that were not scientifically designed{Puhan, 2006 8195 /id} or used a technique (electrical stimulation) that was not well tolerated.{Lequeux, 2005 7514 /id}

Detailed description

Overview: Subjects with OSAS (but not using continuous positive airway pressure CPAP) will undergo NAP physical therapy of the upper airway, utilizing a physiologically determined training pressure and protocol, three days a week (approximately 30 minute sessions each) for a period of three months. Overnight sleep studies (PSGs) will be performed pre- and post-study. Primary outcome measurements include the pre- and post-study Apnea/Hypopnea index (AHI) and daytime hypersomnolence symptom scores. Each subject's total study time is approximately a 3-4 month period which includes screening visit, pre and post study overnight polysomnography, and therapy sessions of 3-4 a week for three months.

Conditions

• Obstructive Sleep Apnea Syndrome

Interventions

Type	Name	Description
OTHER	Negative airway pressure delivery	Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2014-04-10
• Last updated: 2015-04-15
• Results posted: 2015-03-25

Locations

1 site across 1 country: United States