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Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers (NIRS-OSAS)

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ClinicalTrials.gov Identifier: NCT00591591
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : March 11, 2011
Last Update Posted : March 16, 2011
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Carle Foundation Hospital
University of Illinois at Chicago
University of California, Irvine
Information provided by:
ISS, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Device: OxiplexTS Phase 3

Detailed Description:

Frequency domain near-infrared spectroscopy (NIRS) offers the advantage of performing safe, non-invasive, transcranial, quantitative measurements of brain oxygenation and hemodynamics in real-time. These characteristics make NIRS the ideal tool to study physiological and pathological processes of the brain, in settings ranging from research and diagnostic laboratories to intensive care units and operating rooms.

Scientists recently developed the first commercially available absolute near-infrared oximeter, called OxiplexTS. This portable device will be used to study brain vascular autoregulatory responses (such as responses to hypoxia and hypercapnia) in persons with obstructive sleep apnea (OSA). These responses to allow for the assessment of brain vascular health. The OxiplexTS device will be beneficial in identifying persons at risk for cerebrovascular disease. Polysomnography (PSG), which is currently used to assess sleep disorders, gives important information on the function of different systems, however, it does not provide information on brain oxygenation and hemodynamics during sleep. The assessment of these factors, via NIRS, in persons with OSA is crucial because of the high prevalence of the disorder and the significant cardio/cerebrovascular health risk it represents.

The specific aim of this trial is to make OxiplexTS a clinically usable instrument, especially for research and clinical diagnosis and monitoring of sleep disorders. An additional goal is to determine the usefulness of this instrument for providing measurements in various clinical situations including intensive care management or prolonged surgical procedures, such as cardiothoracic surgery that require critical information of brain oxygenation and hemodynamics. This trial emerges from previous phase I and phase II studies which determined the feasibility of using OxiplexTS to assess brain vascular autoregulatory responses to hypoxic stimuli.

Approximately 300 participants will be recruited from a pool of healthy individuals, individuals with OSA, and volunteers undergoing overnight diagnostic or therapeutic PSG for suspected OSA.

Participants will be divided into two groups: healthy controls and persons with OSA. Both groups will undergo standard overnight sleep study or PSG. In addition to the standard PSG (with or without Continuous Positive Airway Pressure (CPAP)), the study researchers will add the OxiplexTS—allowing them to assess brain oxygenation and hemodynamics during sleep. The hemodynamic patterns of the healthy controls will be compared to those of persons with OSA. Participants with OSA who undergo PSG/CPAP will be tested with the OxiplexTS, as well. Their PSG and PSG/CPAP data will be compared.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 309 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Absolute Near-Infrared Brain Oximeter
Study Start Date : August 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: OSA
Persons with suspected obstructive sleep apnea (OSA) undergoning overnight sleep evaluation
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.
No Intervention: Controls
Healthy controls



Primary Outcome Measures :
  1. Percentage of Oxygen Saturation in the Brain During Sleep [ Time Frame: 6 hours of sleep ]
  2. Oxyhemoglobin Concentration in the Brain During Sleep [ Time Frame: 6 hours of sleep ]
  3. Total Hemoglobin Concentration in the Brain During Sleep [ Time Frame: 6 hours of sleep ]
  4. Deoxy-Hemoglobin Concentration in the Brain During Sleep [ Time Frame: 6 hours of sleep ]

Secondary Outcome Measures :
  1. Apnea Hypopnea Index (AHI is the Index of Severity That Combines Apneas and Hypopneas) Determined During the Routine Sleep Study [ Time Frame: 6 hours of sleep ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy individuals (controls)
  • Individuals undergoing overnight polysomnography foe suspected obstructive sleep apnea

Exclusion Criteria:

  • Documented severe cardiovascular disease.
  • Documented cerebrovascular disease
  • Documented cardiopulmonary disease
  • Pregnancy

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): NCT00591591


Locations
United States, California
University of California-Irvine Sleep Disorders Center, 101 The City Drive South, Bldg. 22C, 2nd Floor, Rt. 23
Orange, California, United States, 92868
Stanford Sleep Disorders Clinic, Psychiatry Building, 401 Quarry Road
Stanford, California, United States, 94305
United States, Illinois
Center of Sleep and Ventilatory Disorders, University of Illinois Medical Center at Chicago, 2200 W Harrison
Chicago, Illinois, United States, 60612
Carle Regional Sleep Disorders Center, Carle Foundation Hospital, 611 West Park Street
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
ISS, Inc.
National Institute of Neurological Disorders and Stroke (NINDS)
Carle Foundation Hospital
University of Illinois at Chicago
University of California, Irvine
Investigators
Principal Investigator: Antonios Michalos, M.D., M.S. ISS, Inc.

Additional Information:
Publications:
Responsible Party: Antonios Michalos, M.D., M.S./Director of Medical Research, Principal Investigator, ISS, Inc.
ClinicalTrials.gov Identifier: NCT00591591     History of Changes
Other Study ID Numbers: R44NS040597 ( U.S. NIH Grant/Contract )
2R44NS040597-04 ( U.S. NIH Grant/Contract )
GRANT00130523 ( Other Identifier: NIH NINDS )
RNS040597C ( Other Identifier: NIH NINDS )
First Posted: January 11, 2008    Key Record Dates
Results First Posted: March 11, 2011
Last Update Posted: March 16, 2011
Last Verified: February 2011

Keywords provided by ISS, Inc.:
Obstructive Sleep Apnea Syndrome
sleep disordered breathing
polysomnography (psg)
continuous positive airway pressure (cpap)
brain vascular autoregulation
brain tissue oxygenation
near-infrared spectroscopy
Obstructive Sleep Apnea

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 Wake Disorders
Nervous System Diseases