Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Carle Foundation Hospital
University of Illinois at Chicago
University of California, Irvine
Information provided by:
ISS, Inc. Identifier:
First received: December 21, 2007
Last updated: March 10, 2011
Last verified: February 2011

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 Intervention Phase
Obstructive Sleep Apnea Syndrome
Device: OxiplexTS
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Absolute Near-Infrared Brain Oximeter

Resource links provided by NLM:

Further study details as provided by ISS, Inc.:

Primary Outcome Measures:
  • Percentage of Oxygen Saturation in the Brain During Sleep [ Time Frame: 6 hours of sleep ] [ Designated as safety issue: No ]
  • Oxyhemoglobin Concentration in the Brain During Sleep [ Time Frame: 6 hours of sleep ] [ Designated as safety issue: No ]
  • Total Hemoglobin Concentration in the Brain During Sleep [ Time Frame: 6 hours of sleep ] [ Designated as safety issue: No ]
  • Deoxy-Hemoglobin Concentration in the Brain During Sleep [ Time Frame: 6 hours of sleep ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 309
Study Start Date: August 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
Sponsors and Collaborators
ISS, Inc.
Carle Foundation Hospital
University of Illinois at Chicago
University of California, Irvine
Principal Investigator: Antonios Michalos, M.D., M.S. ISS, Inc.
  More Information

Additional Information:
Responsible Party: Antonios Michalos, M.D., M.S./Director of Medical Research, Principal Investigator, ISS, Inc. Identifier: NCT00591591     History of Changes
Other Study ID Numbers: R44NS040597, 2R44NS040597-04, GRANT00130523, RNS040597C
Study First Received: December 21, 2007
Results First Received: September 22, 2010
Last Updated: March 10, 2011
Health Authority: United States: Federal Government

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:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Nervous System Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic processed this record on February 25, 2015