Status:
COMPLETED
Study of Provent Treatment of Obstructive Sleep Apnea in Patients Who Are Non-compliant With CPAP
Lead Sponsor:
St. Luke's Hospital, Chesterfield, Missouri
Collaborating Sponsors:
Ventus Medical, Inc.
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of the proposed investigation is to evaluate the efficacy of the Provent device in a sample of OSA patients who have either refused or been non-adherent with PAP treatment. Both ...
Eligibility Criteria
Inclusion
- Current signs and symptoms consistent with a diagnosis of OSA in the opinion of the study physician
- Rejection of PAP treatment or minimally adherent with PAP treatment
- Use of the Provent device for a specified amount of time each night during three consecutive nights of the trial period
- AHI \> 15, or AHI \> 10 with evidence of CMS-recognized symptoms or co- morbidities, on screening/baseline PSG
- Investigator believes that subject can benefit from OSA treatment
- Subject understands and is willing and able to comply with study requirements
Exclusion
- Use of any device that interferes with nasal or oral breathing
- Persistent blockage of one or both nostrils which prevents airflow in one or both nostrils
- Any chronic sores or lesions on the inside or outside of the nose
- Chronic use of nasal decongestants other than nasal steroids
- History of allergic reaction to acrylic-based adhesives (such as those found in BAND-AIDS®)
- Current acute upper respiratory (including nasal, sinus, or middle ear) inflammation or infection or perforation of the tympanic membrane (may be re-considered for participation after the acute episode resolves)
- History of frequent and/or poorly treated severe nasal allergies or sinusitis which may interfere with the ability to use Provent
- Severe respiratory disorders (including respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum, etc.).
- Pathologically low blood pressure.
- Narcolepsy, idiopathic hypersomnolence, chronic insomnia, restless legs syndrome, REM sleep behavior disorder or any other diagnosed or suspected sleep disorder other than OSA that could affect the likelihood of apneas/hypopneas during a PSG.
- Periodic limb movement arousal index (PLMAI) \> 10 on the screening/baseline PSG.
- Current use of diurnal or nocturnal supplemental oxygen
- Currently working night or rotating shifts
- Consumption of \> 10 caffeinated beverages per day (approximately 1000 mg per day)
- History of severe cardiovascular disease, including New York Heart Association Class III or IV heart failure, coronary artery disease with angina or myocardial infarction in the past 6 months, stroke in the past 6 months
- History of cardiac rhythm disturbance (defined as a 5-beat run of sustained ventricular tachycardia or bradycardia if \< 30 beats per min for a 10-second run or previously undiagnosed and untreated atrial fibrillation or Mobitz II or third-degree heart block)
- Current psychiatric disorder with psychotic features.
- Pregnant or trying to become pregnant
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00901771
Start Date
May 1 2009
End Date
December 1 2009
Last Update
June 15 2010
Active Locations (1)
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1
Sleep Medicine and Research Center at St. Luke's Hospital
Chesterfield, Missouri, United States, 63017