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Obstructive Sleep Apnea SyndromePhase 3NIRS-OSASNCT00591591

Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers

A Phase 3 study testing OxiplexTS in people with Obstructive Sleep Apnea Syndrome, run by ISS, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Obstructive Sleep Apnea Syndrome
What is being tested?
OxiplexTS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
309 participants
Where
4 sitesUnited States
Study dates
Aug 2007to Jun 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy individuals (controls)
  • Individuals undergoing overnight polysomnography foe suspected obstructive sleep apnea

Who cannot join

  • Documented severe cardiovascular disease.
  • Documented cerebrovascular disease
  • Documented cardiopulmonary disease
  • Pregnancy

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Center of Sleep and Ventilatory Disorders, University of Illinois Medical Center at Chicago, 2200 W Harrison

    Chicago, Illinois, 60612

  • University of California-Irvine Sleep Disorders Center, 101 The City Drive South, Bldg. 22C, 2nd Floor, Rt. 23

    Orange, California, 92868

  • Stanford Sleep Disorders Clinic, Psychiatry Building, 401 Quarry Road

    Stanford, California, 94305

  • Carle Regional Sleep Disorders Center, Carle Foundation Hospital, 611 West Park Street

    Urbana, Illinois, 61801

Other trials in United States

About this study

Official title: Absolute Near-Infrared Brain Oximeter

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.

Read the 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.

Being tested
OxiplexTS
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
Medical subject headings
Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Microcephaly, Primary Autosomal Recessive, 6

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxiplexTSDevice

    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.

Study groups in NCT00591591
Study groupRoleWhat they receive
OSAExperimentalPersons with suspected obstructive sleep apnea (OSA) undergoning overnight sleep evaluation
Receives: Device: OxiplexTS
ControlsNo interventionHealthy controls

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Oxygen Saturation in the Brain During Sleep

    Measured: 6 hours of sleep

  2. Oxyhemoglobin Concentration in the Brain During Sleep

    Measured: 6 hours of sleep

  3. Total Hemoglobin Concentration in the Brain During Sleep

    Measured: 6 hours of sleep

  4. Deoxy-Hemoglobin Concentration in the Brain During Sleep

    Measured: 6 hours of sleep

Secondary outcomes (1)

  1. Apnea Hypopnea Index (AHI is the Index of Severity That Combines Apneas and Hypopneas) Determined During the Routine Sleep Study

    Measured: 6 hours of sleep

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2008 (estimated)
  2. Study startAug 2007
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
309 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00591591
Sponsor's protocol ID
R44NS040597
Other IDs
2R44NS040597-04, GRANT00130523, RNS040597C
Acronym
NIRS-OSAS
Status last verified
Feb 2011
First submitted
21 Dec 2007
Last updated
16 Mar 2011
Data monitoring committee
Yes

Publications

  • 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.

  • 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.

    PubMed 15381340

  • 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.

    PubMed 18246984

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OxiplexTS in people with Obstructive Sleep Apnea Syndrome, run by ISS, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Oxygen Saturation in the Brain During Sleep (time frame: 6 hours of sleep). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00591591, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2011.

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