Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)

Study Overview
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Brief Summary
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To study the effects of two combination therapies for patients with obstructive sleep apnea (OSA) who have been both intolerant to Positive Airway Pressure (PAP) therapy and sub-therapeutic to oral appliance therapy. Hypothesis 1. There is a difference between Continuous Positive Airway Pressure (CPAP) vs CPAP/Oral Appliance (OA) connect vs CPAP/OA disconnected in terms of: Apnea Hypopnea Index (AHI) reduction Amount of side effects Amount of Leaks Hours of use (compliance) CPAP pressure 2. There is a difference between connected and disconnected for the following symptoms: Epworth sleepiness Scale (ESS) Functional Outcomes of Sleep Questionnaire (FOSQ) Side effects Study Design - randomized prospective parallel

Official Title
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Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)

Conditions
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Treatment for Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Nuance Pro
* Device: autoPAP
* Device: TAP PAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Baseline diagnosis AHI > or = 5 plus ESS . or = 10. PAP Intolerance Partial Response to oral appliance therapy: AHI > 5 Age: > 18 Exclusion Criteria: History of daily use of alcohol, narcotics or Central Nervous System (CNS) depressants. Diagnosis of Central Sleep Apnea Pregnancy Edentulous Prisoners

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination Therapy with Preferred Mask<br>Preferred Mask refers to a type of existing medical mask used for PAP therapy. | Device: Nuance Pro<br>* Study compares Nuance Pro plus Automatic Positive Airway Pressure (autoPAP) vs TAP PAP plus autoPAP<br>* Other names: TAP PAP;Device: autoPAP<br>* autoPAP<br>|
| Experimental: Combination Therapy with Custom Mask<br>Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance. | Device: autoPAP<br>* autoPAP<br>Device: TAP PAP<br>* TAP PAP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index | Episodes per hour that the patient experiences apneas and/or hypopneas | 2 months | 
| PAP Pressure | The pressure required to treat the patient successfully | 2 months | 
| Leaks | The Liters/Minute of leaking of the PAP machine | 2 months | 
| Hours of Use | The average hours of use per night of each of the combination therapies | 2 months | 
| Epworth Sleepiness Scale (ESS) | The ESS is a self-administered questionnaire with 8 questions. The score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life. | 2 months | 
| Functional Outcomes Sleep Questionnaire (FOSQ) | FOSQ is a disease specific quality of life questionnaire to determine how sleepiness interferes one's quality of life. The total score range from 5 to 20 (10 questions, 1-4 points per each). The lower values represent a worse quality of life. | 2 months | 
| Intolerance Questionnaire | This questionnaire consists of 4 questions to determine the frequency of 4 typical side-effects from positive airway pressure therapy. The score ranges from 0 to 16 (4 questions, 0-4 points per each). The higher value represent worse side effects. | 2 months |