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
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Syndrome||Device: OxiplexTS||Phase 3|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Absolute Near-Infrared Brain Oximeter|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
Persons with suspected obstructive sleep apnea (OSA) undergoning overnight sleep evaluation
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
- Percentage of Oxygen Saturation in the Brain During Sleep [ Time Frame: 6 hours of sleep ]
- Oxyhemoglobin Concentration in the Brain During Sleep [ Time Frame: 6 hours of sleep ]
- Total Hemoglobin Concentration in the Brain During Sleep [ Time Frame: 6 hours of sleep ]
- Deoxy-Hemoglobin Concentration in the Brain During Sleep [ Time Frame: 6 hours of sleep ]
- 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 ]
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
|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|
|Principal Investigator:||Antonios Michalos, M.D., M.S.||ISS, Inc.|