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

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ClinicalTrials.gov Identifier: NCT00591591
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : March 11, 2011
Last Update Posted : March 16, 2011
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Carle Foundation Hospital
University of Illinois at Chicago
University of California, Irvine
Information provided by:
ISS, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Obstructive Sleep Apnea Syndrome
Intervention Device: OxiplexTS
Enrollment 309

Recruitment Details

OSAS sufferers and Controls have been recruited an tested at:

  1. Center of Sleep Disorders of the University of Illinois at Chicago.
  2. Regional Sleep Disorders Center at Carle Foundation Hospital (Urbana,IL).
  3. University of California-Irvine Medical Center-Center for Sleep Disorders (UCIMC)
  4. Stanford University -Sleep Disorders Clinic
Pre-assignment Details  
Arm/Group Title Controls Obsructive Sleep Apnea Sufferers
Hide Arm/Group Description Healthy controls Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
Period Title: Overall Study
Started 176 133
Completed 165 94
Not Completed 11 39
Reason Not Completed
Withdrawal by Subject             1             37
Lack of Efficacy             10             2
Arm/Group Title Controls Obsructive Sleep Apnea Sufferers Total
Hide Arm/Group Description Healthy controls Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome Total of all reporting groups
Overall Number of Baseline Participants 176 133 309
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 133 participants 309 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
176
 100.0%
133
 100.0%
309
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 176 participants 133 participants 309 participants
34.9  (10.15) 41.7  (8.9) 38.3  (9.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 133 participants 309 participants
Female
111
  63.1%
86
  64.7%
197
  63.8%
Male
65
  36.9%
47
  35.3%
112
  36.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 176 participants 133 participants 309 participants
176 133 309
1.Primary Outcome
Title Percentage of Oxygen Saturation in the Brain During Sleep
Hide Description [Not Specified]
Time Frame 6 hours of sleep
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy & OSA Subjects.
Arm/Group Title Controls Obsructive Sleep Apnea Sufferers
Hide Arm/Group Description:
Healthy controls
Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
Overall Number of Participants Analyzed 176 133
Mean (Standard Deviation)
Unit of Measure: Percentage of brain oxygen saturation
53.462  (8.825) 53.13  (11.24)
2.Primary Outcome
Title Oxyhemoglobin Concentration in the Brain During Sleep
Hide Description [Not Specified]
Time Frame 6 hours of sleep
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy & OSA Subjects.
Arm/Group Title Controls Obsructive Sleep Apnea Sufferers
Hide Arm/Group Description:
Healthy controls
Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
Overall Number of Participants Analyzed 176 133
Mean (Standard Deviation)
Unit of Measure: µM
18.82  (7.81) 18.36  (7.96)
3.Primary Outcome
Title Total Hemoglobin Concentration in the Brain During Sleep
Hide Description [Not Specified]
Time Frame 6 hours of sleep
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Controls Obsructive Sleep Apnea Sufferers
Hide Arm/Group Description:
Healthy controls
Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
Overall Number of Participants Analyzed 176 133
Mean (Standard Deviation)
Unit of Measure: µM
34.38  (11.72) 33.71  (11.22)
4.Primary Outcome
Title Deoxy-Hemoglobin Concentration in the Brain During Sleep
Hide Description [Not Specified]
Time Frame 6 hours of sleep
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy & OSA Subjects.
Arm/Group Title Controls Obsructive Sleep Apnea Sufferers
Hide Arm/Group Description:
Healthy controls
Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
Overall Number of Participants Analyzed 176 133
Mean (Standard Deviation)
Unit of Measure: µM
15.82  (6.73) 15.41  (4.71)
5.Secondary Outcome
Title Apnea Hypopnea Index (AHI is the Index of Severity That Combines Apneas and Hypopneas) Determined During the Routine Sleep Study
Hide Description [Not Specified]
Time Frame 6 hours of sleep
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Controls Obsructive Sleep Apnea Sufferers
Hide Arm/Group Description:
Healthy controls
Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
Overall Number of Participants Analyzed 176 133
Mean (Standard Deviation)
Unit of Measure: Number of apnea/hypopnea per sleep hour
1.78  (2.41) 42.4  (32.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Controls Obsructive Sleep Apnea Sufferers
Hide Arm/Group Description Healthy controls Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
All-Cause Mortality
Controls Obsructive Sleep Apnea Sufferers
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Controls Obsructive Sleep Apnea Sufferers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/176 (0.00%)   0/133 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Controls Obsructive Sleep Apnea Sufferers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/176 (0.00%)   0/133 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Antonios Michalos
Organization: ISS, Inc., Champaign Illinois
Phone: 217-359-8681
Responsible Party: Antonios Michalos, M.D., M.S./Director of Medical Research, Principal Investigator, ISS, Inc.
ClinicalTrials.gov Identifier: NCT00591591     History of Changes
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 )
First Submitted: December 21, 2007
First Posted: January 11, 2008
Results First Submitted: September 22, 2010
Results First Posted: March 11, 2011
Last Update Posted: March 16, 2011