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
1 other identifier
interventional
250
1 country
17
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2008
Shorter than P25 for phase_4
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2008
CompletedFirst Posted
Study publicly available on registry
October 15, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedApril 1, 2010
March 1, 2010
10 months
October 13, 2008
March 31, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Reduction in AHI, Oxygen desat index, Arousal index & Duration of snoring w/ device on/off;ESS,Patient acceptance,Device-related AEs & SAEs
3 months
Study Arms (2)
Provent
ACTIVE COMPARATORThose receiving the active device
Sham
SHAM COMPARATORThose receiving sham device
Interventions
Application of active device (Provent)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Pulmonary Associates
Glendale, Arizona, 85306, United States
Pulmonary Associates
Phoenix, Arizona, 85006, United States
Stanford Center for Human Sleep Research
Redwood City, California, 94063, United States
Gaylord Sleep Medicine
Wallingford, Connecticut, 06492, United States
University Of Florida College of Medicine
Gainesville, Florida, 32610, United States
Sleep Disorders Center of Georgia
Atlanta, Georgia, 30342, United States
Chicago Sleep Group of Suburban Lung Associates
Elk Grove Village, Illinois, 60007, United States
Kentucky Research Group
Louisville, Kentucky, 40217, United States
Sleep Health Center
Brighton, Massachusetts, 02135, United States
Wayne State University
Detroit, Michigan, 48201, United States
Borgess Research Institute
Kalamazoo, Michigan, 49048, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Sleep Medicine and Research Center
Chesterfield, Missouri, 63017, United States
The Corvallis Clinic
Corvallis, Oregon, 97330, United States
SleepMed of South Carolina
Columbia, South Carolina, 29201, United States
Sleep Medicine Associates of Texas
Dallas, Texas, 75231, United States
Sleep Therapy and Research Center
San Antonio, Texas, 07829, United States
Related Publications (1)
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.
PMID: 21461326DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard B Berry, M.D.
University of Florida
- STUDY DIRECTOR
Connie A Rey
Ventus Medical
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 13, 2008
First Posted
October 15, 2008
Study Start
November 1, 2008
Primary Completion
September 1, 2009
Study Completion
December 1, 2009
Last Updated
April 1, 2010
Record last verified: 2010-03