Status:
COMPLETED
Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea
Lead Sponsor:
Ventus Medical, Inc.
Conditions:
Obstructive Sleep Apnea Hypopnea
OSA
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 E...
Detailed Description
Please see summary above
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00772044
Start Date
November 1 2008
End Date
December 1 2009
Last Update
April 1 2010
Active Locations (17)
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1
Pulmonary Associates
Glendale, Arizona, United States, 85306
2
Pulmonary Associates
Phoenix, Arizona, United States, 85006
3
Stanford Center for Human Sleep Research
Redwood City, California, United States, 94063
4
Gaylord Sleep Medicine
Wallingford, Connecticut, United States, 06492