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

OSA Clinical Trial

— AERO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772044
• Other study ID #: C009
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2008
• Last updated: March 31, 2010
• Start date: November 2008
• Est. completion date: December 2009

Study information

• Verified date: March 2010
• Source: Ventus Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Description:

Please see summary above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Hypopnea
• OSA
• OSAH
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Provent Professional Sleep Apnea Therapy Device
Application of active device (Provent)
• Sham Device
Sham device will be applied

Locations

Country	Name	City	State
United States	Sleep Disorders Center of Georgia	Atlanta	Georgia
United States	Sleep Health Center	Brighton	Massachusetts
United States	Sleep Medicine and Research Center	Chesterfield	Missouri
United States	SleepMed of South Carolina	Columbia	South Carolina
United States	The Corvallis Clinic	Corvallis	Oregon
United States	Sleep Medicine Associates of Texas	Dallas	Texas
United States	Wayne State University	Detroit	Michigan
United States	Chicago Sleep Group of Suburban Lung Associates	Elk Grove Village	Illinois
United States	University Of Florida College of Medicine	Gainesville	Florida
United States	Pulmonary Associates	Glendale	Arizona
United States	Borgess Research Institute	Kalamazoo	Michigan
United States	Kentucky Research Group	Louisville	Kentucky
United States	Pulmonary Associates	Phoenix	Arizona
United States	Stanford Center for Human Sleep Research	Redwood City	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Sleep Therapy and Research Center	San Antonio	Texas
United States	Gaylord Sleep Medicine	Wallingford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Ventus Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Reduction in AHI, Oxygen desat index, Arousal index & Duration of snoring w/ device on/off;ESS,Patient acceptance,Device-related AEs & SAEs		3 months	Yes