CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 309 enrolled
Drug / intervention
OxiplexTSdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00591591
NCT00591591Phase 3Completed
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Absolute Near-Infrared Brain Oximeter

ISS, Inc.·interventional·Posted Jan 11, 2008·Updated Mar 16, 2011

In Brief

A Phase 3 clinical trial evaluating OxiplexTS for Obstructive Sleep Apnea Syndrome. Completed, enrolled 309 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea Syndrome
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS), Carle Foundation Hospital, University of Illinois at Chicago, University of California, Irvine

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2008
Enrollment StartAug 1, 2007
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.5 years ago

Interventions

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.