Upper Airway Physical Therapy for the Treatment of Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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
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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.

Official Title
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Upper Airway Physical Therapy for the Treatment of Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Other: Negative airway pressure delivery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative airway pressure delivery<br>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. | Other: Negative airway pressure delivery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delta of Apnea Hypopnea Index (AHI) as Measured by Polysomnography (PSG) | 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. | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea Syndrome (OSAS), Sleep Apnea