study of provent treatment of obstructive sleep apnea in patients who are non-compliant with cpap

Conditions: Sleep Apnea, Obstructive

Summary: 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

Keywords: sleep sleep apnea, obstructive osa osah