Sleep Apnea, Obstructive
Conditions
Keywords
Sleep, Sleep Apnea, Obstructive, OSA, OSAH
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.
Interventions
DEVICEProvent
This is a non-randomized, single-arm, case series study. All subjects will receive Provent device.
Sponsors
Ventus Medical, Inc.
St. Luke's Hospital, Chesterfield, Missouri
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Week 1 AHI as compared to Screening/Baseline AHI | 1 week |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed