Clinical trial NCT00591591: Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers
Official title: Absolute Near-Infrared Brain Oximeter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obstructive Sleep Apnea Syndrome
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
Lead sponsor: ISS, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Carle Foundation Hospital
name: University of Illinois at Chicago
name: University of California, Irvine
First posted: 2008-01-11
Enrollment: 309
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Oxygen Saturation in the Brain During Sleep
timeFrame: 6 hours of sleep
measure: Oxyhemoglobin Concentration in the Brain During Sleep
timeFrame: 6 hours of sleep
measure: Total Hemoglobin Concentration in the Brain During Sleep
timeFrame: 6 hours of sleep
measure: Deoxy-Hemoglobin Concentration in the Brain During Sleep
timeFrame: 6 hours of sleep
Secondary outcomes:
measure: Apnea Hypopnea Index (AHI is the Index of Severity That Combines Apneas and Hypopneas) Determined During the Routine Sleep Study
timeFrame: 6 hours of sleep
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California-Irvine Sleep Disorders Center, 101 The City Drive South, Bldg. 22C, 2nd Floor, Rt. 23
state: California
city: Stanford
country: United States
facility: Stanford Sleep Disorders Clinic, Psychiatry Building, 401 Quarry Road
state: California
city: Chicago
country: United States
facility: Center of Sleep and Ventilatory Disorders, University of Illinois Medical Center at Chicago, 2200 W Harrison
state: Illinois
city: Urbana
country: United States
facility: Carle Regional Sleep Disorders Center, Carle Foundation Hospital, 611 West Park Street
state: Illinois
Study officials:
affiliation: ISS, Inc.
name: Antonios Michalos, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.