Positive Pressure Treatment of Obstructive Sleep Apnea

Study Overview
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Brief Summary
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Six month at home positive pressure therapy study; which mode of therapy will lead to better adherence and patient outcomes?

Detailed Description
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Three arm randomized controlled trial evaluating therapy titration methodologies and device comfort.

Official Title
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Positive Airway Pressure Initiation: Impact of Therapy Mode and Titration Process on Adherence and Outcomes

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Auto AFlex
* Device: Auto CPAP
* Device: CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 - 75 Diagnosis of OSAHS with baseline AHI (Apnea-Hypopnea Index) equal or greater than 15 events/hr of sleep Able and willing to provide written informed consent Agreement to try PAP (positive airway pressure) as initial treatment approach Adequate clinical CPAP titration within two weeks of enrollment Exclusion Criteria: Participation in another interventional research study within the last 30 days The need for more than one titration PSG (polysomnography) The use of sedatives or hypnotics during the titration PSG Major medical or psychiatric condition that would interfere with the demands of the study, adherence to PAP or the ability to commit to follow-up assessment. Prior prescription for, or exposure to PAP therapy within the previous year (except exposure to CPAP during clinical therapy titration.) Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD (chronic obstructive pulmonary disease) or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (>45 mmHG) while awake or participants qualifying for oxygen therapy (arterial saturation < or equal to 88% for more than five minutes). Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days Surgery at any time for the treatment of OSAHS such as uvulopalatopharyngoplasty (UPPP) Presence of untreated or poorly managed, non-OSAHS related sleep disorders: moderate to severe periodic limb movements (greater or equal to 15 per hour with symptoms or arousals) Restless Leg syndrome (greater than 10 per hour) Males experiencing chronic insomnia Use of medications with hypnotic or sedative effects or regular use of night time sedatives or sleeping aids greater than or equal to one night per week. Consumption of ethanol more than 4 nights per week (CAGE criteria) Shift workers

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Auto Aflex<br>auto adjusting positive pressure therapy with AFLEX | Device: Auto AFlex<br>* Positive pressure therapy treatment<br>|
| Active Comparator: Auto CPAP<br>auto adjusting positive pressure therapy | Device: Auto CPAP<br>* Positive pressure therapy treatment<br>|
| Active Comparator: CPAP<br>continuous positive airway pressure | Device: CPAP<br>* Positive pressure therapy treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index | The Apnea-Hyopnea Index is the number of average number of apneas (complete pauses in breathing lasting at least 10 seconds) and hypopneas (decreases in airflow lasting at least 10 seconds) per hour of sleep. This data was compared from the polysomnography (sleep study) data after the first night of device use and at 180 days | Baseline and 180 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Hours of Nightly Use. | The average hours of nightly use is the average number of hours the participant used there device overnight at home during the study. | 180 days | 
| Psychomotor Vigilance Task - Number of Lapses | Psychomotor Vigilance Task-PVT is a 10-min attention/vigilance test. To measure trends of vigilance after 180 days of home use randomized sleep apnea trial. This measured how quickly participants reacted to visual stimulus and counted number of lapses. Lapses (errors of omission) are measured or usually defined as reaction Times ≥ 500 ms. | Baseline and 180 Days | 
| Functional Outcomes of Sleep Questionnaire (FOSQ) | FOSQ is a quality of life questionnaire for sleep disorders. It's a 30 question survey with 5 subgroups: general productivity (8 questions), social outcome (2 questions),activity level (9 questions), vigilance (7 questions) and intimate relationships & sexual activity (4 questions). Scores are provided on a 0 to 4 scale: 0- I don't do this activity for other reasons or missing response 1- Yes, extreme difficulty 4- no difficulty The average score was calculated based upon average sub-scores. The total score was,calculated using the mean of the subscale scores and multiplying the mean by the number of subscales. The range of scores for the total score is 5-20. The measures are designed to assess the impact of disorders of excessive sleepiness on activities of everyday living and the extent to which these abilities are improved by effective treatment. The lower the score the more difficulty a person has carrying out certain activities because they are too sleepy or tired. | Baseline and 180 Days | 
| Attitudes Toward Use | Attitudes Toward Use Questionnaire (ATUQ) a self-efficacy scale based on psychological theories of behavior change and modified from one developed by Stepnowsky and Marler this outcome focused on confidence, expectations and importance. Confidence is a 5 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The scores range from 5 to 25 with 25 being extremely confident. Importance is a 11 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The importance ATU was combined with Exceptions survey, which is 4 questions. The expectations survey is measured on a scale of 1 to 5, with 1 being not at all effective and 5 extremely effective. The scores range from 15 to 75 with 75 being extremely important/ extremely effective. | Baseline and 180 Days | 
| Subjective Assessment of Therapy Comfort. | visual analog scales where used to assess the question in the last month how do you rate the overall comfort of the mask? 0 = very uncomfortable to 100 = very comfortable | 30, 90, and 180 days | 
| Epworth Sleepiness Scale | Epworth Sleepiness Scale is a test that measures sleepiness during daily life activities. This is an 8 question survey. Scores are provided on a 0 to 3 scale: 0 = no chance of dozing = slight chance of dozing = moderate chance of dozing = high chance of dozing Scores range from 0 to 24. The higher the total number, the higher the overall sleepiness. | Baseline and 180 days |