Upper Airway Physical Therapy for the Treatment of Obstructive Sleep Apnea

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}

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

18 and over and any persons who have been diagnosed with OSAS (AHI over 15) and who are not utilizing CPAP

Exclusion criteria

Participants will be excluded if: Pregnant, Breastfeeding or any bleeding abnormalities, there is a major upper airway morphologic abnormality (e.g., retrognathia, Pierre-Robin syndrome), they have had any airway surgery (except tonsillectomy as a child),they regularly use any drugs that are known to depress the central nervous system (such as benzodiazepines, narcotics), they consume 14 alcoholic drinks a week or 2 a day,they are undergoing a current or planned intervention for weight reduction or are morbidly obese (body mass index 40 kg/m2), or they have any unstable medical or psychiatric illnesses.

Treatment and study plan

Negative airway pressure delivery

Other

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.

Primary outcomes

Delta of Apnea Hypopnea Index (AHI) as Measured by Polysomnography (PSG)

Time frame: three months

The pre-study AHI (before the NAP treatment was applied) was measured and quantified and compared to the post study AHI (after three months of NAP treatment) and the difference between pre and post therapy is reported. The AHI is an hourly rate of breathing disturbance (apneas and hypopneas per hour) that is calculated while subjects are evaluated during an overnight sleep study, with polysomnography applied (PSG). For example, while a subject is spending the night in the PSG laboratory sleeping, his/her breathing is evaluated for evidence of apneas and hypopneas during various stages of sleep. Sleep is measured with electroencephalography. And breathing is measure with respiratory excursions via chest/abdominal plethysmography recordings and airflow from the nose/mouth.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Apr 10, 2014
Registry last updated: Apr 15, 2015

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.

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

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