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

Completed · Phase 4 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea Hypopnea, OSA, OSAH

In brief

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

Key facts

Study ID

NCT00772044

Run by

Ventus Medical, Inc.

People needed

250

Starts

2008-11-01

Expected to finish

2009-12-01

Last updated by the study team

2010-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Pulmonary Associates — Glendale, Arizona, United States
• Pulmonary Associates — Phoenix, Arizona, United States
• Stanford Center for Human Sleep Research — Redwood City, California, United States
• Gaylord Sleep Medicine — Wallingford, Connecticut, United States
• University Of Florida College of Medicine — Gainesville, Florida, United States
• Sleep Disorders Center of Georgia — Atlanta, Georgia, United States
• Chicago Sleep Group of Suburban Lung Associates — Elk Grove Village, Illinois, United States
• Kentucky Research Group — Louisville, Kentucky, United States
• Sleep Health Center — Brighton, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• Borgess Research Institute — Kalamazoo, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Sleep Medicine and Research Center — Chesterfield, Missouri, United States
• The Corvallis Clinic — Corvallis, Oregon, United States
• SleepMed of South Carolina — Columbia, South Carolina, United States
• Sleep Medicine Associates of Texas — Dallas, Texas, United States
• Sleep Therapy and Research Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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