Study of Provent Treatment of Obstructive Sleep Apnea in Patients Who Are Non-compliant With CPAP
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Provent
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Sleep, Sleep Apnea, Obstructive, OSA, OSAH
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
Sites / Locations
- Sleep Medicine and Research Center at St. Luke's Hospital
Outcomes
Primary Outcome Measures
Week 1 AHI as compared to Screening/Baseline AHI
Secondary Outcome Measures
Week 5 AHI as compared to Screening/Baseline AHI
Minutes with SaO2 <90%: Week 5 vs. Screening/Baseline
Epworth Sleepiness Scale: Week 5 vs. Baseline
Full Information
NCT ID
NCT00901771
First Posted
May 13, 2009
Last Updated
June 14, 2010
Sponsor
St. Luke's Hospital, Chesterfield, Missouri
Collaborators
Ventus Medical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00901771
Brief Title
Study of Provent Treatment of Obstructive Sleep Apnea in Patients Who Are Non-compliant With CPAP
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 Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
St. Luke's Hospital, Chesterfield, Missouri
Collaborators
Ventus Medical, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Sleep, Sleep Apnea, Obstructive, OSA, OSAH
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Provent
Intervention Description
This is a non-randomized, single-arm, case series study. All subjects will receive Provent device.
Primary Outcome Measure Information:
Title
Week 1 AHI as compared to Screening/Baseline AHI
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Week 5 AHI as compared to Screening/Baseline AHI
Time Frame
5 weeks
Title
Minutes with SaO2 <90%: Week 5 vs. Screening/Baseline
Time Frame
5 weeks
Title
Epworth Sleepiness Scale: Week 5 vs. Baseline
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James K Walsh, Ph.D.
Organizational Affiliation
Sleep Medicine and Research Center at St. Luke's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Medicine and Research Center at St. Luke's Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
12. IPD Sharing Statement
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Study of Provent Treatment of Obstructive Sleep Apnea in Patients Who Are Non-compliant With CPAP
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