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

Ventus Medical

Status and phase: Completed; Phase 4

Conditions: OSAH; Obstructive Sleep Apnea Hypopnea; OSA

Treatments: Device: Sham Device; Device: Provent Professional Sleep Apnea Therapy Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00772044

C009

Details and patient eligibility

About

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

Full description

Please see summary above

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups

Provent

Active Comparator group

Description:

Those receiving the active device

Treatment:

Device: Provent Professional Sleep Apnea Therapy Device

Sham

Sham Comparator group

Description:

Those receiving sham device

Treatment:

Device: Sham Device