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
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea Hypopnea focused on measuring OSA, sleep apnea, apnea, AHI
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
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
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
We'll reach out to this number within 24 hrs