Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): OxiplexTS
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 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