Study of Provent Treatment of Obstructive Sleep Apnea in Patients Who Are Non-compliant With CPAP

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Sleep Apnea, Obstructive	Device: Provent	Not Applicable

Study Design

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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

Arms and Interventions

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Intervention Details:

Device: Provent
This is a non-randomized, single-arm, case series study. All subjects will receive Provent device.

Outcome Measures

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Primary Outcome Measures :

1. Week 1 AHI as compared to Screening/Baseline AHI [ Time Frame: 1 week ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United States, Missouri
Sleep Medicine and Research Center at St. Luke's Hospital
Chesterfield, Missouri, United States, 63017

Sponsors and Collaborators

St. Luke's Hospital, Chesterfield, Missouri

Ventus Medical, Inc.

Investigators

Principal Investigator:	James K Walsh, Ph.D.	Sleep Medicine and Research Center at St. Luke's Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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