Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
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
Official Title
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
Eligibility Criteria
- 1. Age \> 18 years2. Diagnosis of OSA3. AHI \> 10 on diagnostic PSG performed within last 3 months4. Investigator believes that subject can benefit from OSA tx5. Subject understands and is willing and able to comply with study requirements
- 1. Use of any device that interferes with nasal/oral breathing2. Persistent blockage of one or both nostrils3. Any chronic sores or lesions on the inside/outside of the nose4. Chronic use of nasal decongestants other than nasal steroids5. Oxygen saturation \< 75% for \> 10% of the diag. PSG6. Oxygen saturation \< 75% for \> 25% of the first 4 hours of the diag. PSG7. Prior or near-miss motor vehicle accident due to sleepiness (last 12 mo.)8. Current use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect neurocognitive function and/or alertness9. History of allergic reaction to acrylic-based adhesives10. Current acute upper respiratory inflammation/infection or perforation of the tympanic membrane11. History of frequent and/or poorly treated severe nasal allergies or sinusitis12. Narcolepsy, idiopathic hypersomnolence, chronic insomnia, RLS, REM sleep behavior disorder or any other diagnosed or suspected sleep disorder13. Current use of diurnal or nocturnal supplemental oxygen14. History of CPAP use in the home for OSA tx15. History of use of oral appliances for OSA tx16. History of prior surgery for OSA17. Currently working night or rotating shifts18. Consumption of \> 10 caffeinated beverages per day19. History of severe cardiovasc. disease, including NYHA Class III or IV heart failure, CAD with angina or MI/stroke in past 6 months20. History of cardiac rhythm disturbance21. Uncontrolled hypertension (SBP \> 180 or DBP \> 105 mm Hg)22. Uncontrolled hypotension(SBP \< 80 or DBP \< 55 mm Hg23. History of severe respiratory disorders or unstable respiratory disease24. Any other serious, uncontrolled medical condition25. Females of child bearing age who are pregnant or intending to become pregnant26. Consumes more than 3 drinks of alcohol/day27. Chronic neurologic disorders28. Cancer, unless in remission for more than 1 year29. Current psychiatric illness30. Smokers whose habit interferes with the overnight PSG31. Any known illicit drug usage
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Chia-Yu Cardell
6507217576
View on ClinicalTrials.gov
