NCT00901771CompletedNot Applicable
A Non-randomized, Case Series Study of the Effectiveness of Provent Treatment of Obstructive Sleep Apnea Patients Who Are Non-compliant or Minimally Adherent With Positive Airway Pressure Therapy
St. Luke's Hospital, Chesterfield, Missouri2 sites in 1 country50 target enrollmentStarted: May 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Week 1 AHI as compared to Screening/Baseline AHI
Study Overview
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 initial efficacy (evaluated after approximately one week with Provent) and efficacy after approximately 5 weeks in patients who demonstrate initial efficacy will be assessed. A secondary objective is to assess adherence with Provent treatment during the 5-week evaluation period.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Week 1 AHI as compared to Screening/Baseline AHI
Time Frame: 1 week
Secondary Outcomes
- Week 5 AHI as compared to Screening/Baseline AHI(5 weeks)
- Minutes with SaO2 <90%: Week 5 vs. Screening/Baseline(5 weeks)
- Epworth Sleepiness Scale: Week 5 vs. Baseline(5 weeks)
Investigators
Study Sites (2)
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