- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00591591
Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers (NIRS-OSAS)
Absolute Near-Infrared Brain Oximeter
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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Orange, California, United States, 92868
- University of California-Irvine Sleep Disorders Center, 101 The City Drive South, Bldg. 22C, 2nd Floor, Rt. 23
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Stanford, California, United States, 94305
- Stanford Sleep Disorders Clinic, Psychiatry Building, 401 Quarry Road
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Illinois
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Chicago, Illinois, United States, 60612
- Center of Sleep and Ventilatory Disorders, University of Illinois Medical Center at Chicago, 2200 W Harrison
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Urbana, Illinois, United States, 61801
- Carle Regional Sleep Disorders Center, Carle Foundation Hospital, 611 West Park Street
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OSA
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
Healthy controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Oxygen Saturation in the Brain During Sleep
Time Frame: 6 hours of sleep
|
6 hours of sleep
|
Oxyhemoglobin Concentration in the Brain During Sleep
Time Frame: 6 hours of sleep
|
6 hours of sleep
|
Total Hemoglobin Concentration in the Brain During Sleep
Time Frame: 6 hours of sleep
|
6 hours of sleep
|
Deoxy-Hemoglobin Concentration in the Brain During Sleep
Time Frame: 6 hours of sleep
|
6 hours of sleep
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 hours of sleep
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Antonios Michalos, M.D., M.S., ISS, Inc.
Publications and helpful links
General Publications
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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