Sleep Apnea Treatment With Expiratory Resistance(Provent™)

Study Overview
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Brief Summary
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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.

Official Title
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Sleep Apnea Treatment With Expiratory Resistance(Provent™)

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: Treatment sleep study (Provent™ device used)
* Other: Baseline sleep study (No device)
* Other: Physiology sleep study (Provent™ on/off)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm - Sleep apnea<br>Participants with sleep apnea will be recruited for the study. Each participant will undergo 3 sleep studies to assess the effect of the Provent™ device. Participants will only use the device while they are in the sleep laboratory. They will not use the device at home between sleep studies . Baseline sleep study (No device) - Assess the effects of no Provent™ on sleep apnea severity. Treatment sleep study (Provent™ device used) - Assess the effects of Provent™ on sleep apnea severity Physiology sleep study (Provent™ on/off) - Assess the physiological effects of the Provent™ device on breathing during sleep. | Device: Treatment sleep study (Provent™ device used)<br>* The patient's sleep apnea severity is determined on this night while using the Provent™ device. The patient only uses the Provent™ device on this night (single night use only).<br>Other: Baseline sleep study (No device)<br>* The patient sleeps for 1 night in the sleep lab to determine their baseline sleep apnea severity without sleeping with the Provent device.<br>Other: Physiology sleep study (Provent™ on/off)<br>* During this sleep study night, the patient is sleeping with a modified Provent™ device that can be turned on and off to assess changes in airflow during the night (single night use only).Provent™ on/off is bracketed in 10 minute intervals during stable stage 2 sleep.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AHI | The primary outcome was the change in the apnea hypopnea index (AHI). Sleep apnea events are defined as apneas and hypopneas.The AHI is a measure of sleep apnea severity. An AHI > 5 event/h is considered abnormal. AHI values are typically categorized as 5-15 events/hr = mild; 15-30 events/hr = moderate; and > 30 events/hr = severe. For this study we compared the change in AHI from the baseline sleep study (No Provent) compared to the treatment night sleep study (on Provent). | Comparisons were made between the 2 nights | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea, treatment, collapsibility, expiratory nasal resistance