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Portable Monitoring for Diagnosis and Management of Sleep Apnea

NCT00642486 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 373

Last updated 2025-08-05

No results posted yet for this study

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.

Conditions

  • Sleep Apnea, Obstructive

Interventions

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.

OTHER

Standard polysomnography (PSG)

laboratory-based testing

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    collaborator OTHER

  • The Cleveland Clinic

    collaborator OTHER

  • MetroHealth Medical Center

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • University of Minnesota

    collaborator OTHER

  • Northwestern University

    collaborator OTHER

  • University of Wisconsin, Madison

    collaborator OTHER

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Carol L Rosen, MD · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-07-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00642486 on ClinicalTrials.gov