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Portable Monitoring for Diagnosis and Management of Sleep Apnea (HomePAP)

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ClinicalTrials.gov Identifier: NCT00642486
Recruitment Status : Completed
First Posted : March 25, 2008
Last Update Posted : May 27, 2010
Sponsor:
Collaborators:
University Hospitals Cleveland Medical Center
The Cleveland Clinic
MetroHealth Medical Center
University of Washington
University of Minnesota - Clinical and Translational Science Institute
Northwestern University
University of Wisconsin, Madison
Information provided by:
Case Western Reserve University

Brief Summary:
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 or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Other: Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex) Other: Standard polysomnography (PSG) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 373 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Portable Monitoring in the Diagnosis and Management of Obstructive Sleep Apnea
Study Start Date : February 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: 1
laboratory-based testing
Other: Standard polysomnography (PSG)
laboratory-based testing

Active Comparator: 2
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.




Primary Outcome Measures :
  1. Acceptance of CPAP treatment [ Time Frame: from diagnosis to effective treatment ]

Secondary Outcome Measures :
  1. Compliance with CPAP therapy [ Time Frame: 1 and 3 month post acceptance ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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) Apnea-hypopnea index >= 15 on diagnostic testing to continue in study

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642486


Locations
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United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Western Reserve University
University Hospitals Cleveland Medical Center
The Cleveland Clinic
MetroHealth Medical Center
University of Washington
University of Minnesota - Clinical and Translational Science Institute
Northwestern University
University of Wisconsin, Madison
Investigators
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Principal Investigator: Carol L Rosen, MD Case Western Reserve University

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

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Responsible Party: Carol L. Rosen, MD/PI, Case Western Reserve University School of Medicine
ClinicalTrials.gov Identifier: NCT00642486     History of Changes
Other Study ID Numbers: ASMF 38-PM-07
First Posted: March 25, 2008    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: March 2008

Keywords provided by Case Western Reserve University:
treatment
positive airway pressure
compliance
cost effectiveness
clinical trial

Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases