Trial record 1 of 4 for:
Ventus
Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea (AERO)
This study has been completed.
Sponsor:
Ventus Medical, Inc.
Information provided by:
Ventus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00772044
First received: October 13, 2008
Last updated: March 31, 2010
Last verified: March 2010
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
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 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Provent
Those receiving the active device
|
Device: Provent Professional Sleep Apnea Therapy Device
Application of active device (Provent)
Other Name: Provent
|
|
Sham Comparator: Sham
Those receiving sham device
|
Device: Sham Device
Sham device will be applied
Other Name: Sham device
|
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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772044
Locations
| United States, Arizona | |
| Pulmonary Associates | |
| Glendale, Arizona, United States, 85306 | |
| Pulmonary Associates | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Stanford Center for Human Sleep Research | |
| Redwood City, California, United States, 94063 | |
| United States, Connecticut | |
| Gaylord Sleep Medicine | |
| Wallingford, Connecticut, United States, 06492 | |
| United States, Florida | |
| University Of Florida College of Medicine | |
| Gainesville, Florida, United States, 32610 | |
| United States, Georgia | |
| Sleep Disorders Center of Georgia | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| Chicago Sleep Group of Suburban Lung Associates | |
| Elk Grove Village, Illinois, United States, 60007 | |
| United States, Kentucky | |
| Kentucky Research Group | |
| Louisville, Kentucky, United States, 40217 | |
| United States, Massachusetts | |
| Sleep Health Center | |
| Brighton, Massachusetts, United States, 02135 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| Borgess Research Institute | |
| Kalamazoo, Michigan, United States, 49048 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Sleep Medicine and Research Center | |
| Chesterfield, Missouri, United States, 63017 | |
| United States, Oregon | |
| The Corvallis Clinic | |
| Corvallis, Oregon, United States, 97330 | |
| United States, South Carolina | |
| SleepMed of South Carolina | |
| Columbia, South Carolina, United States, 29201 | |
| United States, Texas | |
| Sleep Medicine Associates of Texas | |
| Dallas, Texas, United States, 75231 | |
| Sleep Therapy and Research Center | |
| San Antonio, Texas, United States, 07829 | |
Sponsors and Collaborators
Ventus Medical, Inc.
Investigators
| Principal Investigator: | Richard B Berry, M.D. | University of Florida |
| Study Director: | Connie A Rey | Ventus Medical |
More Information
No publications provided by Ventus Medical, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Connie Rey, Director, Clinical Affairs, Ventus Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00772044 History of Changes |
| Other Study ID Numbers: | C009 |
| Study First Received: | October 13, 2008 |
| Last Updated: | March 31, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ventus Medical, Inc.:
|
OSA sleep apnea apnea AHI |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013