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

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.


Eligibility Criteria:
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