Obstructive Sleep Apnea Hypopnea, OSA, OSAH
Conditions
Keywords
OSA, sleep apnea, apnea, AHI
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 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
Please see summary above
Interventions
DEVICEProvent Professional Sleep Apnea Therapy Device
Application of active device (Provent)
DEVICESham Device
Sham device will be applied
Sponsors
Ventus Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years 2. Diagnosis of OSA 3. AHI \> 10 on diagnostic PSG performed within last 3 months 4. Investigator believes that subject can benefit from OSA tx 5. Subject understands and is willing and able to comply with study requirements
Exclusion criteria
1. Use of any device that interferes with nasal/oral breathing 2. Persistent blockage of one or both nostrils 3. Any chronic sores or lesions on the inside/outside of the nose 4. Chronic use of nasal decongestants other than nasal steroids 5. Oxygen saturation \< 75% for \> 10% of the diag. PSG 6. Oxygen saturation \< 75% for \> 25% of the first 4 hours of the diag. PSG 7. 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 alertness 9. History of allergic reaction to acrylic-based adhesives 10. Current acute upper respiratory inflammation/infection or perforation of the tympanic membrane 11. History of frequent and/or poorly treated severe nasal allergies or sinusitis 12. Narcolepsy, idiopathic hypersomnolence, chronic insomnia, RLS, REM sleep behavior disorder or any other diagnosed or suspected sleep disorder 13. Current use of diurnal or nocturnal supplemental oxygen 14. History of CPAP use in the home for OSA tx 15. History of use of oral appliances for OSA tx 16. History of prior surgery for OSA 17. Currently working night or rotating shifts 18. Consumption of \> 10 caffeinated beverages per day 19. History of severe cardiovasc. disease, including NYHA Class III or IV heart failure, CAD with angina or MI/stroke in past 6 months 20. History of cardiac rhythm disturbance 21. Uncontrolled hypertension (SBP \> 180 or DBP \> 105 mm Hg) 22. Uncontrolled hypotension(SBP \< 80 or DBP \< 55 mm Hg 23. History of severe respiratory disorders or unstable respiratory disease 24. Any other serious, uncontrolled medical condition 25. Females of child bearing age who are pregnant or intending to become pregnant 26. Consumes more than 3 drinks of alcohol/day 27. Chronic neurologic disorders 28. Cancer, unless in remission for more than 1 year 29. Current psychiatric illness 30. Smokers whose habit interferes with the overnight PSG 31. Any known illicit drug usage
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed