Portable Monitoring for Diagnosis and Management of Sleep Apnea - Full Text View

Sponsors and Collaborators:	Case Western Reserve University University Hospital Case Medical Center The Cleveland Clinic MetroHealth Medical Center University of Washington University of Minnesota Northwestern University
Information provided by:	Case Western Reserve University
ClinicalTrials.gov Identifier:	NCT00642486

Purpose

This multi-site project compares compares the efficiency of a home-based portable monitoring strategy to a standard of care sleep laboratory-based strategy for the diagnosis and positive airway pressure treatment of obstructive sleep apnea in adults.

Condition	Intervention
Sleep Apnea, Obstructive	Other: Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex) Other: Standard polysomnography (PSG)

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Portable Monitoring in the Diagnosis and Management of Obstructive Sleep Apnea

Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:

Acceptance of CPAP treatment [ Time Frame: from diagnosis to effective treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compliance with CPAP therapy [ Time Frame: 1 and 3 month post acceptance ] [ Designated as safety issue: No ]

Estimated Enrollment:	372
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator laboratory-based testing	Other: Standard polysomnography (PSG) laboratory-based testing
2: Active Comparator home-based testing	Other: Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex) portable, home-based using the Embla Embletta X30 system as the diagnostic device and the Respironic REMStar Auto M series with CFlex as the PAP titration device.

Detailed Description:

The study is a randomized, parallel group, unblinded, multicenter study that compares two approaches [home-based, portable monitoring (PM) versus attended, laboratory-based polysomnography (PSG) (Lab)] in adults, at least 18 years of age, with a moderate to high probability of obstructive sleep apnea (OSA) and who have been referred to sleep medicine specialists at AASM-accredited sleep centers for evaluation and/or management. The study is designed to compare the utility of the two approaches (PM group vs. Lab group) for the diagnosis and management of OSA in adults. Approximately 372 eligible adults will be randomized at screening to either the PM or Lab arm (186 per arm), undergo baseline OSA testing to confirm diagnosis and study eligibility, then receive positive airway pressure (PAP) titration studies to determine the level of pressure needed to treat their OSA. For qualifying participants, the titration study will be lab-based in the Lab group and be home-based using a commercially available portable, automatic PAP device (APAP) in the PM group. All qualifying study participants will have access to study CPAP equipment and supplies to treat their OSA. Primary outcomes (time from diagnosis to effective treatment, patient outcomes, and relative resource utilization) are determined at 1 and 3 months after starting CPAP treatment. Study participants who complete all of their study visits will keep their CPAP machine at the end of the study.

Eligibility

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

Criteria

Inclusion Criteria:

Intermediate to high probability of having OSA based on an adjusted neck circumference > 43 cm (17 inches)
Presence of excessive daytime sleepiness (Epworth sleepiness scale ≥ 12)

Exclusion Criteria:

Severe chronic insomnia, other condition with < 4 hrs of sleep per night
Unstable medical conditions
Major psychiatric diagnosis
Unable to undergo home testing
Concerns about unsafe driving
Severe COPD or restrictive lung disease
Chronic narcotic use
Alcohol abuse
History of cataplexy
Moderate to severe restless legs syndrome symptoms
Pre-existing diagnosis of sleep apnea
Prior experience with positive airway pressure treatment of sleep apnea
Anticipated upper airway surgery or gastric bypass surgery in 4 months
Decisional impairment for consenting
Hypoventilation syndrome, identified in the medical record
Waking oxygen saturation < 92%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642486

Contacts

Contact: Carol L. Rosen, MD	216 844 3267	carol.rosen@case.edu
Contact: Lisa Fardy, MSN	216 844 4836	lisa.fardy@case.edu

Locations

United States, Ohio
University Hospitals Case Medical Center	Recruiting
Cleveland, Ohio, United States, 44106
Principal Investigator: Carol L Rosen, MD

Sponsors and Collaborators

Case Western Reserve University

University Hospital Case Medical Center

The Cleveland Clinic

MetroHealth Medical Center

University of Washington

University of Minnesota

Northwestern University

Investigators

Principal Investigator:

Carol L Rosen, MD

Case Western Reserve University

More Information

Responsible Party:	Case Western Reserve University School of Medicine ( Carol L. Rosen, MD/PI )
Study ID Numbers:	ASMF 38-PM-07
Study First Received:	March 24, 2008
Last Updated:	March 24, 2008
ClinicalTrials.gov Identifier:	NCT00642486
Health Authority:	United States: Institutional Review Board

Keywords provided by Case Western Reserve University:

treatment
positive airway pressure
compliance
cost effectiveness
clinical trial

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009