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Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers

Absolute Near-Infrared Brain Oximeter

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00591591
Acronym
NIRS-OSAS
Enrollment
309
Registered
2008-01-11
Start date
2007-08-31
Completion date
2010-06-30
Last updated
2011-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DEVICEOxiplexTS

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.

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
Carle Foundation Hospital
CollaboratorOTHER
University of Illinois at Chicago
CollaboratorOTHER
University of California, Irvine
CollaboratorOTHER
ISS, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
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

Design outcomes

Primary

MeasureTime frame
Deoxy-Hemoglobin Concentration in the Brain During Sleep6 hours of sleep
Percentage of Oxygen Saturation in the Brain During Sleep6 hours of sleep
Oxyhemoglobin Concentration in the Brain During Sleep6 hours of sleep
Total Hemoglobin Concentration in the Brain During Sleep6 hours of sleep

Secondary

MeasureTime frame
Apnea Hypopnea Index (AHI is the Index of Severity That Combines Apneas and Hypopneas) Determined During the Routine Sleep Study6 hours of sleep

Countries

United States

Participant flow

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

Participants by arm

ArmCount
Controls
Healthy controls
176
Obsructive Sleep Apnea Sufferers
Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
133
Total309

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLack of Efficacy102
Overall StudyWithdrawal by Subject137

Baseline characteristics

CharacteristicControlsTotalObsructive Sleep Apnea Sufferers
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
176 Participants309 Participants133 Participants
Age Continuous34.9 years
STANDARD_DEVIATION 10.15
38.3 years
STANDARD_DEVIATION 9.52
41.7 years
STANDARD_DEVIATION 8.9
Region of Enrollment
United States
176 participants309 participants133 participants
Sex: Female, Male
Female
111 Participants197 Participants86 Participants
Sex: Female, Male
Male
65 Participants112 Participants47 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1760 / 133
serious
Total, serious adverse events
0 / 1760 / 133

Outcome results

Primary

Deoxy-Hemoglobin Concentration in the Brain During Sleep

Time frame: 6 hours of sleep

Population: Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy \& OSA Subjects.

ArmMeasureValue (MEAN)Dispersion
ControlsDeoxy-Hemoglobin Concentration in the Brain During Sleep15.82 µMStandard Deviation 6.73
Obsructive Sleep Apnea SufferersDeoxy-Hemoglobin Concentration in the Brain During Sleep15.41 µMStandard Deviation 4.71
Primary

Oxyhemoglobin Concentration in the Brain During Sleep

Time frame: 6 hours of sleep

Population: Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy \& OSA Subjects.

ArmMeasureValue (MEAN)Dispersion
ControlsOxyhemoglobin Concentration in the Brain During Sleep18.82 µMStandard Deviation 7.81
Obsructive Sleep Apnea SufferersOxyhemoglobin Concentration in the Brain During Sleep18.36 µMStandard Deviation 7.96
Primary

Percentage of Oxygen Saturation in the Brain During Sleep

Time frame: 6 hours of sleep

Population: Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy \& OSA Subjects.

ArmMeasureValue (MEAN)Dispersion
ControlsPercentage of Oxygen Saturation in the Brain During Sleep53.462 Percentage of brain oxygen saturationStandard Deviation 8.825
Obsructive Sleep Apnea SufferersPercentage of Oxygen Saturation in the Brain During Sleep53.13 Percentage of brain oxygen saturationStandard Deviation 11.24
Primary

Total Hemoglobin Concentration in the Brain During Sleep

Time frame: 6 hours of sleep

ArmMeasureValue (MEAN)Dispersion
ControlsTotal Hemoglobin Concentration in the Brain During Sleep34.38 µMStandard Deviation 11.72
Obsructive Sleep Apnea SufferersTotal Hemoglobin Concentration in the Brain During Sleep33.71 µMStandard Deviation 11.22
Secondary

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

ArmMeasureValue (MEAN)Dispersion
ControlsApnea Hypopnea Index (AHI is the Index of Severity That Combines Apneas and Hypopneas) Determined During the Routine Sleep Study1.78 Number of apnea/hypopnea per sleep hourStandard Deviation 2.41
Obsructive Sleep Apnea SufferersApnea Hypopnea Index (AHI is the Index of Severity That Combines Apneas and Hypopneas) Determined During the Routine Sleep Study42.4 Number of apnea/hypopnea per sleep hourStandard Deviation 32.6

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026