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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00772044
Other study ID # C009
Secondary ID
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


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
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