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Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers

NCT00591591 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 309

Last updated 2011-03-16

Study results available
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Summary

The goal of this trial is to assess the performance of the OxiplexTS-an absolute near-infrared oximeter-as an instrument to measure brain oxygenation and hemodynamics in sleep medicine as well as in the broader field of cardiovascular/cerebrovascular diagnostics.

Conditions

  • Obstructive Sleep Apnea Syndrome

Interventions

DEVICE

OxiplexTS

OxiplexTS is a Frequency Domain Near-Infrared Tissue oximeter which provides absolute values of tissue oxygenation in real time. It also provides physiological quantities of oxy, deoxy and total hemoglobin concentration, which form the basis for the functional measurement of brain hemodynamics. Both the control and OSA groups will undergo standard overnight sleep study (PSG). In addition to the standard PSG, with or without Continuous Positive Airway Pressure (CPAP), we will add the OxiplexTS, allowing us to assess brain oxygenation and hemodynamics during sleep. The hemodynamic patterns of the healthy controls will be compared to the OSA sufferers. Participants with OSA who undergo PSG/CPAP will be also tested with the OxiplexTS. Their PSGs and PSG/CPAP data will be compared.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Carle Foundation Hospital

    collaborator OTHER

  • University of Illinois at Chicago

    collaborator OTHER

  • University of California, Irvine

    collaborator OTHER

  • ISS, Inc.

    lead INDUSTRY

Principal Investigators

  • Antonios Michalos, M.D., M.S. · ISS, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

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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 NCT00591591 on ClinicalTrials.gov