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

This study has been completed.
Sponsor:
Collaborator:
Ventus Medical, Inc.
Information provided by:
St. Luke's Hospital, Chesterfield, Missouri
ClinicalTrials.gov Identifier:
NCT00901771
First received: May 13, 2009
Last updated: June 14, 2010
Last verified: June 2010
  Purpose

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 Intervention
Sleep Apnea, Obstructive
Device: Provent

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by St. Luke's Hospital, Chesterfield, Missouri:

Primary Outcome Measures:
  • Week 1 AHI as compared to Screening/Baseline AHI [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Week 5 AHI as compared to Screening/Baseline AHI [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Minutes with SaO2 <90%: Week 5 vs. Screening/Baseline [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Epworth Sleepiness Scale: Week 5 vs. Baseline [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2009
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Provent
    This is a non-randomized, single-arm, case series study. All subjects will receive Provent device.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901771

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

No publications provided

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
Study First Received: May 13, 2009
Last Updated: June 14, 2010
Health Authority: United States: Institutional Review Board

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
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 27, 2014