Sleep Apnea Treatment With Expiratory Resistance(Provent™)

Sleep Apnea Treatment With Expiratory Resistance(Provent™)

Continuous positive airway pressure (CPAP) continues to be the primary therapy prescribed for the treatment of obstructive sleep apnea (OSA). Although effective, adherence to CPAP is suboptimal in many patients, making alternative therapies desirable. Recently, a novel device (Provent™) has been developed for the treatment of snoring and OSA. The purpose of the current study is to examine how well the Provent™ device treats OSA with particular attention to the how the it may treat sleep apnea and who may most likely benefit from the use of this treatment.

Inclusion Criteria:

• Consenting adults over the age of 18
• Diagnosed obstructive sleep apnea (defined as an RDI > 5 events per hour & ≥ 90% of disordered breathing events classified as obstructive)

Exclusion Criteria:

• Total sleep time from previous sleep study < 4 hours (240 minutes)
• Severe bilateral nasal obstruction (apparent mouth breathing at rest)
• Documented history of lung diseases, as defined below:
• Daytime hypercapnia (PaCO2 > 45 mmHg)
• Baseline SaO2 ≤ 92%
• Chronic lung disease except mild intermittent or mild persistent asthma
• Cor pulmonale
• Documented clinical cardiovascular disease, as defined below:
• Myocardial infarction in past 3 months
• Revascularization procedure in past 3 months
• Implanted cardiac pacemaker or ICD
• Unstable arrhythmias
• Congestive heart failure with ejection fraction < 40%
• Uncontrolled hypertension (BP > 190/110)
• History of end stage renal disease (on dialysis)
• History of end stage liver disease, such as:
• Jaundice
• Ascites
• History of recurrent gastrointestinal bleeding
• Transjugular intrahepatic portosystemic shunt (TIPS) ;
• Sleep disorders other than obstructive sleep apnea, such as:
• Narcolepsy
• Restless leg syndrome
• Periodic limb movements causing an arousal index of > 5 per hour
• Transportation industry worker (commercial truck or bus drivers, airline pilots)
• Known pregnancy (by self report)
• Known coagulopathy or anticoagulant use (e.g. coumadin) other than aspirin.
• Allergy to lidocaine