Phase 3
N=309
Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers
Obstructive Sleep Apnea Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00591591 ↗Enrolled (actual)
309
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Percentage of Oxygen Saturation in the Brain During Sleep — 53.462; 53.13 Percentage of brain oxygen saturation
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OxiplexTS (Device)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- ISS, Inc.
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Oxygen Saturation in the Brain During Sleep |
53.462; 53.13 | — |
| PRIMARY Oxyhemoglobin Concentration in the Brain During Sleep |
18.82; 18.36 | — |
| PRIMARY Total Hemoglobin Concentration in the Brain During Sleep |
34.38; 33.71 | — |
| PRIMARY Deoxy-Hemoglobin Concentration in the Brain During Sleep |
15.82; 15.41 | — |
| SECONDARY Apnea Hypopnea Index (AHI is the Index of Severity That Combines Apneas and Hypopneas) Determined During the Routine Sleep Study |
1.78; 42.4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00591591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.