Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers
NIRS-OSAS
Absolute Near-Infrared Brain Oximeter
4 other identifiers
interventional
309
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2007
Typical duration for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
March 11, 2011
CompletedMarch 16, 2011
February 1, 2011
2.8 years
December 21, 2007
September 22, 2010
March 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage of Oxygen Saturation in the Brain During Sleep
6 hours of sleep
Oxyhemoglobin Concentration in the Brain During Sleep
6 hours of sleep
Total Hemoglobin Concentration in the Brain During Sleep
6 hours of sleep
Deoxy-Hemoglobin Concentration in the Brain During Sleep
6 hours of sleep
Secondary Outcomes (1)
Apnea Hypopnea Index (AHI is the Index of Severity That Combines Apneas and Hypopneas) Determined During the Routine Sleep Study
6 hours of sleep
Study Arms (2)
OSA
EXPERIMENTALPersons with suspected obstructive sleep apnea (OSA) undergoning overnight sleep evaluation
Controls
NO INTERVENTIONHealthy controls
Interventions
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.
Eligibility Criteria
You may qualify if:
- Healthy individuals (controls)
- Individuals undergoing overnight polysomnography foe suspected obstructive sleep apnea
You may not qualify if:
- Documented severe cardiovascular disease.
- Documented cerebrovascular disease
- Documented cardiopulmonary disease
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ISS, Inc.lead
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- Carle Foundation Hospitalcollaborator
- University of Illinois at Chicagocollaborator
- University of California, Irvinecollaborator
Study Sites (4)
University of California-Irvine Sleep Disorders Center, 101 The City Drive South, Bldg. 22C, 2nd Floor, Rt. 23
Orange, California, 92868, United States
Stanford Sleep Disorders Clinic, Psychiatry Building, 401 Quarry Road
Stanford, California, 94305, United States
Center of Sleep and Ventilatory Disorders, University of Illinois Medical Center at Chicago, 2200 W Harrison
Chicago, Illinois, 60612, United States
Carle Regional Sleep Disorders Center, Carle Foundation Hospital, 611 West Park Street
Urbana, Illinois, 61801, United States
Related Publications (3)
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.
BACKGROUNDSafonova 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.
PMID: 15381340BACKGROUNDOlopade 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.
PMID: 18246984BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Antonios Michalos
- Organization
- ISS, Inc., Champaign Illinois
Study Officials
- PRINCIPAL INVESTIGATOR
Antonios Michalos, M.D., M.S.
ISS, Inc.
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 11, 2008
Study Start
August 1, 2007
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
March 16, 2011
Results First Posted
March 11, 2011
Record last verified: 2011-02