Study of Provent Treatment of Obstructive Sleep Apnea in Patients Who Are Non-compliant With CPAP

Study Overview
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Brief Summary
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The primary objective of the proposed investigation is to evaluate the efficacy of the Provent device in a sample of OSA patients who have either refused or been non-adherent with PAP treatment. Both initial efficacy (evaluated after approximately one week with Provent) and efficacy after approximately 5 weeks in patients who demonstrate initial efficacy will be assessed. A secondary objective is to assess adherence with Provent treatment during the 5-week evaluation period.

Official Title
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A Non-randomized, Case Series Study of the Effectiveness of Provent Treatment of Obstructive Sleep Apnea Patients Who Are Non-compliant or Minimally Adherent With Positive Airway Pressure Therapy

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: Provent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current signs and symptoms consistent with a diagnosis of OSA in the opinion of the study physician Rejection of PAP treatment or minimally adherent with PAP treatment Use of the Provent device for a specified amount of time each night during three consecutive nights of the trial period AHI > 15, or AHI > 10 with evidence of CMS-recognized symptoms or co- morbidities, on screening/baseline PSG Investigator believes that subject can benefit from OSA treatment Subject understands and is willing and able to comply with study requirements Exclusion Criteria: Use of any device that interferes with nasal or oral breathing Persistent blockage of one or both nostrils which prevents airflow in one or both nostrils Any chronic sores or lesions on the inside or outside of the nose Chronic use of nasal decongestants other than nasal steroids History of allergic reaction to acrylic-based adhesives (such as those found in BAND-AIDS®) Current acute upper respiratory (including nasal, sinus, or middle ear) inflammation or infection or perforation of the tympanic membrane (may be re-considered for participation after the acute episode resolves) History of frequent and/or poorly treated severe nasal allergies or sinusitis which may interfere with the ability to use Provent Severe respiratory disorders (including respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum, etc.). Pathologically low blood pressure. Narcolepsy, idiopathic hypersomnolence, chronic insomnia, restless legs syndrome, REM sleep behavior disorder or any other diagnosed or suspected sleep disorder other than OSA that could affect the likelihood of apneas/hypopneas during a PSG. Periodic limb movement arousal index (PLMAI) > 10 on the screening/baseline PSG. Current use of diurnal or nocturnal supplemental oxygen Currently working night or rotating shifts Consumption of > 10 caffeinated beverages per day (approximately 1000 mg per day) History of severe cardiovascular disease, including New York Heart Association Class III or IV heart failure, coronary artery disease with angina or myocardial infarction in the past 6 months, stroke in the past 6 months History of cardiac rhythm disturbance (defined as a 5-beat run of sustained ventricular tachycardia or bradycardia if < 30 beats per min for a 10-second run or previously undiagnosed and untreated atrial fibrillation or Mobitz II or third-degree heart block) Current psychiatric disorder with psychotic features. Pregnant or trying to become pregnant

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Provent|This is a non-randomized, single-arm, case series study. All subjects will receive Provent device.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Week 1 AHI as compared to Screening/Baseline AHI |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Week 5 AHI as compared to Screening/Baseline AHI |  | 5 weeks | 
| Minutes with SaO2 <90%: Week 5 vs. Screening/Baseline |  | 5 weeks | 
| Epworth Sleepiness Scale: Week 5 vs. Baseline |  | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Sleep Apnea, Obstructive, OSA, OSAH