Study of Provent Treatment of Obstructive Sleep Apnea in Patients Who Are Non-compliant With CPAP
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ClinicalTrials.gov Identifier: NCT00901771 |
Recruitment Status
:
Completed
First Posted
: May 14, 2009
Last Update Posted
: June 15, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Apnea, Obstructive | Device: Provent | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | October 2009 |
Actual Study Completion Date : | December 2009 |

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Device: Provent
- Week 1 AHI as compared to Screening/Baseline AHI [ Time Frame: 1 week ]
- Week 5 AHI as compared to Screening/Baseline AHI [ Time Frame: 5 weeks ]
- Minutes with SaO2 <90%: Week 5 vs. Screening/Baseline [ Time Frame: 5 weeks ]
- Epworth Sleepiness Scale: Week 5 vs. Baseline [ Time Frame: 5 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901771
United States, Missouri | |
Sleep Medicine and Research Center at St. Luke's Hospital | |
Chesterfield, Missouri, United States, 63017 |
Principal Investigator: | James K Walsh, Ph.D. | Sleep Medicine and Research Center at St. Luke's Hospital |
Responsible Party: | James K. Walsh, Ph.D., Sleep Medicine and Research Center at St. Luke's Hospital |
ClinicalTrials.gov Identifier: | NCT00901771 History of Changes |
Other Study ID Numbers: |
Ventus C020 |
First Posted: | May 14, 2009 Key Record Dates |
Last Update Posted: | June 15, 2010 |
Last Verified: | June 2010 |
Keywords provided by St. Luke's Hospital, Chesterfield, Missouri:
Sleep Sleep Apnea, Obstructive OSA OSAH |
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 Wake Disorders Nervous System Diseases |