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

NCT ID: NCT00901771

Last Updated: 2010-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-12-31

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.

Conditions

Sleep Apnea, Obstructive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Provent

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ventus Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

St. Luke's Hospital, Chesterfield, Missouri

OTHER

Sponsor Role: lead

Responsible Party

Sleep Medicine and Research Center at St. Luke's Hospital

Principal Investigators

James K Walsh, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Sleep Medicine and Research Center at St. Luke's Hospital

Locations

Sleep Medicine and Research Center at St. Luke's Hospital

Chesterfield, Missouri, United States

Countries

United States

Other Identifiers

Ventus C020

Identifier Type: -

Identifier Source: org_study_id