Clinical trial NCT00772044: Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea Hypopnea
OSA
OSAH
Keywords: OSA
sleep apnea
apnea
AHI
Lead sponsor: Ventus Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 3 months
Secondary outcomes:
measure: Reduction in AHI, Oxygen desat index, Arousal index & Duration of snoring w/ device on/off;ESS,Patient acceptance,Device-related AEs & SAEs
timeFrame: 3 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pulmonary Associates
state: Arizona
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Redwood City
country: United States
facility: Stanford Center for Human Sleep Research
state: California
city: Wallingford
country: United States
facility: Gaylord Sleep Medicine
state: Connecticut
city: Gainesville
country: United States
facility: University Of Florida College of Medicine
state: Florida
city: Atlanta
country: United States
facility: Sleep Disorders Center of Georgia
state: Georgia
city: Elk Grove Village
country: United States
facility: Chicago Sleep Group of Suburban Lung Associates
state: Illinois
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Brighton
country: United States
facility: Sleep Health Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Research Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chesterfield
country: United States
facility: Sleep Medicine and Research Center
state: Missouri
city: Corvallis
country: United States
facility: The Corvallis Clinic
state: Oregon
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Sleep Medicine Associates of Texas
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy and Research Center
state: Texas
Study officials:
affiliation: University of Florida
name: Richard B Berry, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ventus Medical
name: Connie A Rey
role: STUDY_DIRECTOR
References:
citation: Berry RB, Kryger MH, Massie CA. A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial. Sleep. 2011 Apr 1;34(4):479-85. doi: 10.1093/sleep/34.4.479.