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

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

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

Study Overview

• Status: Completed
• Conditions: OSA; Obstructive Sleep Apnea Hypopnea; OSAH
• Intervention / Treatment: Device: Provent Professional Sleep Apnea Therapy Device; Device: Sham Device

Detailed Description

Please see summary above

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Pulmonary Associates
    • Phoenix, Arizona, United States, 85006
      • Pulmonary Associates
  • California
    • Redwood City, California, United States, 94063
      • Stanford Center for Human Sleep Research
  • Connecticut
    • Wallingford, Connecticut, United States, 06492
      • Gaylord Sleep Medicine
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida College of Medicine
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Sleep Disorders Center of Georgia
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Chicago Sleep Group of Suburban Lung Associates
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Kentucky Research Group
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Sleep Health Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University
    • Kalamazoo, Michigan, United States, 49048
      • Borgess Research Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Sleep Medicine and Research Center
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • The Corvallis Clinic
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • SleepMed of South Carolina
  • Texas
    • Dallas, Texas, United States, 75231
      • Sleep Medicine Associates of Texas
    • San Antonio, Texas, United States, 07829
      • Sleep Therapy and Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Provent; Those receiving the active device	Device: Provent Professional Sleep Apnea Therapy Device; Application of active device (Provent); Other Names: Provent
SHAM_COMPARATOR: Sham; Those receiving sham device	Device: Sham Device; Sham device will be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction in AHI, Oxygen desat index, Arousal index & Duration of snoring w/ device on/off;ESS,Patient acceptance,Device-related AEs & SAEs	3 months

Collaborators and Investigators

• Sponsor: Ventus Medical, Inc.
• Investigators: Principal Investigator: Richard B Berry, M.D., University of Florida; Study Director: Connie A Rey, Ventus Medical

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): September 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: October 13, 2008
• First Submitted That Met QC Criteria: October 14, 2008
• First Posted (ESTIMATE): October 15, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 1, 2010
• Last Update Submitted That Met QC Criteria: March 31, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: apnea; OSA; sleep apnea; AHI
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: C009