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

Primary Purpose

Obstructive Sleep Apnea Hypopnea, OSA, OSAH

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Provent Professional Sleep Apnea Therapy Device
Sham Device
Sponsored by
Ventus Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Hypopnea focused on measuring OSA, sleep apnea, apnea, AHI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pulmonary Associates
  • Pulmonary Associates
  • Stanford Center for Human Sleep Research
  • Gaylord Sleep Medicine
  • University Of Florida College of Medicine
  • Sleep Disorders Center of Georgia
  • Chicago Sleep Group of Suburban Lung Associates
  • Kentucky Research Group
  • Sleep Health Center
  • Wayne State University
  • Borgess Research Institute
  • Mayo Clinic
  • Sleep Medicine and Research Center
  • The Corvallis Clinic
  • SleepMed of South Carolina
  • Sleep Medicine Associates of Texas
  • Sleep Therapy and Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Provent

Sham

Arm Description

Those receiving the active device

Those receiving sham device

Outcomes

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)

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

Full Information

First Posted
October 13, 2008
Last Updated
March 31, 2010
Sponsor
Ventus Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00772044
Brief Title
Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ventus Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Hypopnea, OSA, OSAH
Keywords
OSA, sleep apnea, apnea, AHI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Provent
Arm Type
Active Comparator
Arm Description
Those receiving the active device
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Those receiving sham device
Intervention Type
Device
Intervention Name(s)
Provent Professional Sleep Apnea Therapy Device
Other Intervention Name(s)
Provent
Intervention Description
Application of active device (Provent)
Intervention Type
Device
Intervention Name(s)
Sham Device
Intervention Description
Sham device will be applied
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years Diagnosis of OSA AHI > 10 on diagnostic PSG performed within last 3 months Investigator believes that subject can benefit from OSA tx Subject understands and is willing and able to comply with study requirements Exclusion Criteria: Use of any device that interferes with nasal/oral breathing Persistent blockage of one or both nostrils Any chronic sores or lesions on the inside/outside of the nose Chronic use of nasal decongestants other than nasal steroids Oxygen saturation < 75% for > 10% of the diag. PSG Oxygen saturation < 75% for > 25% of the first 4 hours of the diag. PSG Prior or near-miss motor vehicle accident due to sleepiness (last 12 mo.) Current use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect neurocognitive function and/or alertness History of allergic reaction to acrylic-based adhesives Current acute upper respiratory inflammation/infection or perforation of the tympanic membrane History of frequent and/or poorly treated severe nasal allergies or sinusitis Narcolepsy, idiopathic hypersomnolence, chronic insomnia, RLS, REM sleep behavior disorder or any other diagnosed or suspected sleep disorder Current use of diurnal or nocturnal supplemental oxygen History of CPAP use in the home for OSA tx History of use of oral appliances for OSA tx History of prior surgery for OSA Currently working night or rotating shifts Consumption of > 10 caffeinated beverages per day History of severe cardiovasc. disease, including NYHA Class III or IV heart failure, CAD with angina or MI/stroke in past 6 months History of cardiac rhythm disturbance Uncontrolled hypertension (SBP > 180 or DBP > 105 mm Hg) Uncontrolled hypotension(SBP < 80 or DBP < 55 mm Hg History of severe respiratory disorders or unstable respiratory disease Any other serious, uncontrolled medical condition Females of child bearing age who are pregnant or intending to become pregnant Consumes more than 3 drinks of alcohol/day Chronic neurologic disorders Cancer, unless in remission for more than 1 year Current psychiatric illness Smokers whose habit interferes with the overnight PSG Any known illicit drug usage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard B Berry, M.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Connie A Rey
Organizational Affiliation
Ventus Medical
Official's Role
Study Director
Facility Information:
Facility Name
Pulmonary Associates
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Pulmonary Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Stanford Center for Human Sleep Research
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Gaylord Sleep Medicine
City
Wallingford
State/Province
Connecticut
ZIP/Postal Code
06492
Country
United States
Facility Name
University Of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Sleep Disorders Center of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Chicago Sleep Group of Suburban Lung Associates
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Kentucky Research Group
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Sleep Health Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Borgess Research Institute
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Sleep Medicine and Research Center
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
The Corvallis Clinic
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
SleepMed of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Sleep Medicine Associates of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Sleep Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
07829
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21461326
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.
Results Reference
derived

Learn more about this trial

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

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