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

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

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 Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: Provent

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Week 1 AHI as compared to Screening/Baseline AHI	1 week

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: St. Luke's Hospital, Chesterfield, Missouri
• Collaborators: Ventus Medical, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: May 13, 2009
• First Submitted That Met QC Criteria: May 13, 2009
• First Posted (Estimate): May 14, 2009

Study Record Updates

• Last Update Posted (Estimate): June 15, 2010
• Last Update Submitted That Met QC Criteria: June 14, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: OSA; Sleep; Sleep Apnea, Obstructive; OSAH
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: Ventus C020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No