Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea

Study Overview
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Brief Summary
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Primary Endpoints: •Comparison of difference in AHI at one-week in-lab polysomnography between device on and device off nights, controlling for sleep position (supine vs. non-supine) Secondary Endpoints: By polysomnography, reduction in: AHI with device on vs. off at 3 months, controlling for sleep position Oxygen desaturation index with device on vs. off Arousal index with device on vs. off Duration of snoring with device on vs. off Epworth Sleepiness Scale Patient acceptance, in terms of: Refusal rate at screening Discontinuation rate during follow-up Daily compliance rate Device-related adverse events Serious adverse events

Detailed Description
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Please see summary above

Official Title
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Randomized, Double-blind Study to Compare Safety and Effectiveness of the ProventTM Professional Sleep Apnea Therapy Device to Sham for the Non-invasive Treatment of OSAH

Conditions
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Obstructive Sleep Apnea Hypopnea, OSA, OSAH

Intervention / Treatment
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* Device: Provent Professional Sleep Apnea Therapy Device
* Device: Sham Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Diagnosis of OSA AHI > 10 on diagnostic PSG performed within last 3 months Investigator believes that subject can benefit from OSA tx Subject understands and is willing and able to comply with study requirements Exclusion Criteria: Use of any device that interferes with nasal/oral breathing Persistent blockage of one or both nostrils Any chronic sores or lesions on the inside/outside of the nose Chronic use of nasal decongestants other than nasal steroids Oxygen saturation < 75% for > 10% of the diag. PSG Oxygen saturation < 75% for > 25% of the first 4 hours of the diag. PSG Prior or near-miss motor vehicle accident due to sleepiness (last 12 mo.) Current use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect neurocognitive function and/or alertness History of allergic reaction to acrylic-based adhesives Current acute upper respiratory inflammation/infection or perforation of the tympanic membrane History of frequent and/or poorly treated severe nasal allergies or sinusitis Narcolepsy, idiopathic hypersomnolence, chronic insomnia, RLS, REM sleep behavior disorder or any other diagnosed or suspected sleep disorder Current use of diurnal or nocturnal supplemental oxygen History of CPAP use in the home for OSA tx History of use of oral appliances for OSA tx History of prior surgery for OSA Currently working night or rotating shifts Consumption of > 10 caffeinated beverages per day History of severe cardiovasc. disease, including NYHA Class III or IV heart failure, CAD with angina or MI/stroke in past 6 months History of cardiac rhythm disturbance Uncontrolled hypertension (SBP > 180 or DBP > 105 mm Hg) Uncontrolled hypotension(SBP < 80 or DBP < 55 mm Hg History of severe respiratory disorders or unstable respiratory disease Any other serious, uncontrolled medical condition Females of child bearing age who are pregnant or intending to become pregnant Consumes more than 3 drinks of alcohol/day Chronic neurologic disorders Cancer, unless in remission for more than 1 year Current psychiatric illness Smokers whose habit interferes with the overnight PSG Any known illicit drug usage

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Provent<br>Those receiving the active device | Device: Provent Professional Sleep Apnea Therapy Device<br>* Application of active device (Provent)<br>* Other names: Provent;|
| Sham Comparator: Sham<br>Those receiving sham device | Device: Sham Device<br>* Sham device will be applied<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of difference in AHI at one-week in-lab polysomnography between device on and device off nights, controlling for sleep position (supine vs. non-supine) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in AHI, Oxygen desat index, Arousal index & Duration of snoring w/ device on/off;ESS,Patient acceptance,Device-related AEs & SAEs |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA, sleep apnea, apnea, AHI