Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea - Full Text View

Sponsor:	Ventus Medical, Inc.
Information provided by:	Ventus Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00772044

Purpose

Primary Endpoints:

•Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine)

Secondary Endpoints: By polysomnography, reduction in:

AHI with device on vs. off at 3 months, controlling for sleep position
Oxygen desaturation index with device on vs. off
Arousal index with device on vs. off
Duration of snoring with device on vs. off
Epworth Sleepiness Scale

Patient acceptance, in terms of:

Refusal rate at screening
Discontinuation rate during follow-up
Daily compliance rate
Device-related adverse events
Serious adverse events

Condition	Intervention	Phase
Obstructive Sleep Apnea Hypopnea OSA OSAH	Device: Provent Professional Sleep Apnea Therapy Device Device: Sham Device	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Randomized, Double-blind Study to Compare Safety and Effectiveness of the ProventTM Professional Sleep Apnea Therapy Device to Sham for the Non-invasive Treatment of OSAH

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea Snoring

U.S. FDA Resources

Further study details as provided by Ventus Medical, Inc.:

Primary Outcome Measures:

Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Reduction in AHI, Oxygen desat index, Arousal index & Duration of snoring w/ device on/off;ESS,Patient acceptance,Device-related AEs & SAEs [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	250
Study Start Date:	November 2008
Study Completion Date:	December 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Provent Those receiving the active device	Device: Provent Professional Sleep Apnea Therapy Device Application of active device (Provent) Other Name: Provent
Sham Comparator: Sham Those receiving sham device	Device: Sham Device Sham device will be applied Other Name: Sham device

Detailed Description:

Please see summary above

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > 18 years
Diagnosis of OSA
AHI > 10 on diagnostic PSG performed within last 3 months
Investigator believes that subject can benefit from OSA tx
Subject understands and is willing and able to comply with study requirements

Exclusion Criteria:

Use of any device that interferes with nasal/oral breathing
Persistent blockage of one or both nostrils
Any chronic sores or lesions on the inside/outside of the nose
Chronic use of nasal decongestants other than nasal steroids
Oxygen saturation < 75% for > 10% of the diag. PSG
Oxygen saturation < 75% for > 25% of the first 4 hours of the diag. PSG
Prior or near-miss motor vehicle accident due to sleepiness (last 12 mo.)
Current use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect neurocognitive function and/or alertness
History of allergic reaction to acrylic-based adhesives
Current acute upper respiratory inflammation/infection or perforation of the tympanic membrane
History of frequent and/or poorly treated severe nasal allergies or sinusitis
Narcolepsy, idiopathic hypersomnolence, chronic insomnia, RLS, REM sleep behavior disorder or any other diagnosed or suspected sleep disorder
Current use of diurnal or nocturnal supplemental oxygen
History of CPAP use in the home for OSA tx
History of use of oral appliances for OSA tx
History of prior surgery for OSA
Currently working night or rotating shifts
Consumption of > 10 caffeinated beverages per day
History of severe cardiovasc. disease, including NYHA Class III or IV heart failure, CAD with angina or MI/stroke in past 6 months
History of cardiac rhythm disturbance
Uncontrolled hypertension (SBP > 180 or DBP > 105 mm Hg)
Uncontrolled hypotension(SBP < 80 or DBP < 55 mm Hg
History of severe respiratory disorders or unstable respiratory disease
Any other serious, uncontrolled medical condition
Females of child bearing age who are pregnant or intending to become pregnant
Consumes more than 3 drinks of alcohol/day
Chronic neurologic disorders
Cancer, unless in remission for more than 1 year
Current psychiatric illness
Smokers whose habit interferes with the overnight PSG
Any known illicit drug usage

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772044

Locations

United States, Arizona
Pulmonary Associates
Glendale, Arizona, United States, 85306
Pulmonary Associates
Phoenix, Arizona, United States, 85006
United States, California
Stanford Center for Human Sleep Research
Redwood City, California, United States, 94063
United States, Connecticut
Gaylord Sleep Medicine
Wallingford, Connecticut, United States, 06492
United States, Florida
University Of Florida College of Medicine
Gainesville, Florida, United States, 32610
United States, Georgia
Sleep Disorders Center of Georgia
Atlanta, Georgia, United States, 30342
United States, Illinois
Chicago Sleep Group of Suburban Lung Associates
Elk Grove Village, Illinois, United States, 60007
United States, Kentucky
Kentucky Research Group
Louisville, Kentucky, United States, 40217
United States, Massachusetts
Sleep Health Center
Brighton, Massachusetts, United States, 02135
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
Borgess Research Institute
Kalamazoo, Michigan, United States, 49048
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Sleep Medicine and Research Center
Chesterfield, Missouri, United States, 63017
United States, Oregon
The Corvallis Clinic
Corvallis, Oregon, United States, 97330
United States, South Carolina
SleepMed of South Carolina
Columbia, South Carolina, United States, 29201
United States, Texas
Sleep Medicine Associates of Texas
Dallas, Texas, United States, 75231
Sleep Therapy and Research Center
San Antonio, Texas, United States, 07829

Sponsors and Collaborators

Ventus Medical, Inc.

Investigators

Principal Investigator:	Richard B Berry, M.D.	University of Florida
Study Director:	Connie A Rey	Ventus Medical

More Information

No publications provided by Ventus Medical, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Berry RB, Kryger MH, Massie CA. A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial. Sleep. 2011 Apr 1;34(4):479-85.

Responsible Party:	Connie Rey, Director, Clinical Affairs, Ventus Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00772044 History of Changes
Other Study ID Numbers:	C009
Study First Received:	October 13, 2008
Last Updated:	March 31, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Ventus Medical, Inc.:

OSA
sleep apnea
apnea
AHI

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 Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012