Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers
NCT ID: NCT00591591
Last Updated: 2011-03-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
309 participants
INTERVENTIONAL
2007-08-31
2010-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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OSA
Persons with suspected obstructive sleep apnea (OSA) undergoning overnight sleep evaluation
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.
Controls
Healthy controls
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Individuals undergoing overnight polysomnography foe suspected obstructive sleep apnea
Exclusion Criteria
* Documented cerebrovascular disease
* Documented cardiopulmonary disease
* Pregnancy
21 Years
55 Years
ALL
Yes
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Carle Foundation Hospital
OTHER
University of Illinois at Chicago
OTHER
University of California, Irvine
OTHER
ISS, Inc.
INDUSTRY
Responsible Party
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ISS, Inc.
Principal Investigators
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Antonios Michalos, M.D., M.S.
Role: PRINCIPAL_INVESTIGATOR
ISS, Inc.
Locations
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University of California-Irvine Sleep Disorders Center, 101 The City Drive South, Bldg. 22C, 2nd Floor, Rt. 23
Orange, California, United States
Stanford Sleep Disorders Clinic, Psychiatry Building, 401 Quarry Road
Stanford, California, United States
Center of Sleep and Ventilatory Disorders, University of Illinois Medical Center at Chicago, 2200 W Harrison
Chicago, Illinois, United States
Carle Regional Sleep Disorders Center, Carle Foundation Hospital, 611 West Park Street
Urbana, Illinois, United States
Countries
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References
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Safonova LP, Michalos A , Wolf U, Wolf M, Mantulin WW, Hueber DM and Gratton E. Diminished cerebral circulatory autoregulation in obstructive sleep apnea investigated by near-infrared spectroscopy. Sleep Research on-line 2003; 5(4): 123-132, 2003.
Safonova LP, Michalos A, Wolf U, Wolf M, Hueber DM, Choi JH, Gupta R, Polzonetti C, Mantulin WW, Gratton E. Age-correlated changes in cerebral hemodynamics assessed by near-infrared spectroscopy. Arch Gerontol Geriatr. 2004 Nov-Dec;39(3):207-25. doi: 10.1016/j.archger.2004.03.007.
Olopade CO, Mensah E, Gupta R, Huo D, Picchietti DL, Gratton E, Michalos A. Noninvasive determination of brain tissue oxygenation during sleep in obstructive sleep apnea: a near-infrared spectroscopic approach. Sleep. 2007 Dec;30(12):1747-55. doi: 10.1093/sleep/30.12.1747.
Related Links
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company website
Other Identifiers
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