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: 1. Apnea Hypopnea Index (AHI) reduction 2. Amount of side effects 3. Amount of Leaks 4. Hours of use (compliance) 5. CPAP pressure 2\. There is a difference between connected and disconnected for the following symptoms: 1. Epworth sleepiness Scale (ESS) 2. Functional Outcomes of Sleep Questionnaire (FOSQ) 3. Side effects Study Design - randomized prospective parallel
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
28
Study compares Nuance Pro plus Automatic Positive Airway Pressure (autoPAP) vs TAP PAP plus autoPAP
autoPAP
TAP PAP
J. Michael Adame, DDS, PA
Edinburg, Texas, United States
Apnea-Hypopnea Index
Episodes per hour that the patient experiences apneas and/or hypopneas
Time frame: 2 months
PAP Pressure
The pressure required to treat the patient successfully
Time frame: 2 months
Leaks
The Liters/Minute of leaking of the PAP machine
Time frame: 2 months
Hours of Use
The average hours of use per night of each of the combination therapies
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 months
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