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Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea (AERO)
This study is currently recruiting participants.
Verified by Ventus Medical, Inc., December 2008
Sponsored by: Ventus Medical, Inc.
Information provided by: Ventus Medical, Inc.
ClinicalTrials.gov Identifier: NCT00772044
  Purpose

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

Condition Intervention Phase
Obstructive Sleep Apnea Hypopnea
OSA
OSAH
Device: Provent Professional Sleep Apnea Therapy Device
Device: Sham Device
Phase IV

MedlinePlus related topics: Sleep Apnea Snoring
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Ventus Medical, Inc.:

Primary Outcome Measures:
  • 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) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction in AHI, Oxygen desat index, Arousal index & Duration of snoring w/ device on/off;ESS,Patient acceptance,Device-related AEs & SAEs [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: November 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Provent: Active Comparator
Those receiving the active device
Device: Provent Professional Sleep Apnea Therapy Device
Application of active device (Provent)
Sham: Sham Comparator
Those receiving sham device
Device: Sham Device
Sham device will be applied

Detailed Description:

Please see summary above

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772044

Locations
United States, California
Stanford University Center of Excellence for Sleep Disorder Not yet recruiting
Stanford, California, United States, 94305
Contact: Chia-Yu Cardell     650-725-1915     ccardell@stanford.edu    
Principal Investigator: Clete Kushida, M.D.            
United States, Connecticut
Gaylord Sleep Medicine Recruiting
Wallingford, Connecticut, United States, 06492
Contact: Valerie Assalone     203-741-3411     vassalone@gaylord.org    
Principal Investigator: Meir Kryger, M.D.            
United States, Florida
University Of Florida College of Medicine Recruiting
Gainesville, Florida, United States, 32610
Contact: Susan Purdy     352-371-1735     susan.purdy@medicine.ufl.edu    
Principal Investigator: Richard B Berry, M.D.            
United States, Illinois
Chicago Sleep Group of Suburban Lung Associates Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Judy Goodman     847-981-3660     judy.goodman@sublung.com    
Principal Investigator: Clifford Massie, PhD            
United States, Massachusetts
Neurocare, Inc. Center for Sleep Diagnostics Recruiting
Newton, Massachusetts, United States, 02459
Contact: Jodi Larkin     617-581-6416     jlarkin@neurocareinc.com    
Principal Investigator: Michael Biber, M.D.            
Sleep Health Center Recruiting
Brighton, Massachusetts, United States, 02135
Contact: Melissa Maywalt     617-783-1441 ext 136     Melissa_Maywalt@sleephealth.com    
Principal Investigator: Doug Kirsch, M.D.            
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Roze Kadri     313-745-2361     rkadri@med.wayne.edu    
Principal Investigator: M. Safwan Badr, M.D.            
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Courtney Frerichs     507-255-1997     Frerichs.Courtney@mayo.edu    
Principal Investigator: Sean Caples, D.O.            
United States, Missouri
Sleep Medicine and Research Center Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Nancy Cline     314-205-6325     nancy.cline@stlukes_stl.com    
Principal Investigator: Paula Schweitzer, PhD            
United States, Oregon
The Corvallis Clinic Recruiting
Corvallis, Oregon, United States, 97330
Contact: Julie Carrico     541-754-1275     Julie.carrico@corvallisclinic.com    
Principal Investigator: Mark Reploeg, M.D.            
United States, Texas
Sleep Medicine Associates of Texas Recruiting
Dallas, Texas, United States, 75231
Contact: Linda Bradshaw     214-750-7776     lbradshaw@sleepmed.com    
Principal Investigator: Leon Rosenthal, M.D.            
United States, Washington
Kathryn Severyns Dement Sleep Disorder Center Not yet recruiting
Walla Walla, Washington, United States, 99362
Contact: Kevin Hurlburt     509-525-3320     hurlke@smmc.com    
Principal Investigator: Richard Simon, M.D.            
Sponsors and Collaborators
Ventus Medical, Inc.
Investigators
Principal Investigator: Richard B Berry, M.D. University of Florida College of Medicine
Study Director: Connie A Rey Ventus Medical
  More Information

Responsible Party: Ventus Medical, Inc. ( Connie Rey, Director, Clinical Affairs )
Study ID Numbers: C009
Study First Received: October 13, 2008
Last Updated: December 19, 2008
ClinicalTrials.gov Identifier: NCT00772044  
Health Authority: United States: Institutional Review Board

Keywords provided by Ventus Medical, Inc.:
OSA
sleep apnea
apnea
AHI

Study placed in the following topic categories:
Sleep Apnea Syndromes
Apnea
Clotrimazole
Miconazole
Sleep Apnea, Obstructive
Respiration Disorders
Tioconazole
Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic
Signs and Symptoms
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Salicylhydroxamic acid

Additional relevant MeSH terms:
Trypanocidal Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Therapeutic Uses
Antifungal Agents
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009