A Multi-Center Study to Assess the Performance of Saturation Patterns.
A multi-center, prospective, single-visit study designed to acquire physiologic pulse oximeter waveform data during standard polysomnography (PSG) studies performed at multiple different Sleep Lab Centers. The polysomnograms are clinically indicated studies in patients suspected of having sleep-disordered breathing, including, but not limited to: obstructive sleep apnea, complex sleep apnea and/or central sleep apnea. Subjects who have been prescribed with needing a polysomnography (PSG) will be enrolled into the study.
Obstructive Sleep Apnea
Complex Sleep Apnea
Central Sleep Apnea
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Multi-Center Study to Assess the Performance of the Saturation Pattern Detection (SPD) Software Algorithm.|
- Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA). [ Time Frame: 9 Hours ] [ Designated as safety issue: No ]Sensitivity and specificity were computed from the count of instances in which the Saturation Pattern Detection (SPD) index value (vs. Polysomnography) within a discrete ten minute interval correctly identified a Repetitive Reduction in Airflow (RRiA) as being present within that interval (True Positive), absent (True Negative), or incorrectly identified presence or absence (False Positive and False Negative, respectively). Sensitivity is True Positive divided by True Positive plus False Negative TP/(TP+FN). Specificity is True Positive divided by True Negative plus False Positive TP/(TN+FP).
|Study Start Date:||August 2008|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Polysomnography (PSG) Subjects
Subjects who have been prescribed with needing a polysomnography (PSG) will be enrolled into the study.
|United States, Colorado|
|Broomfield, Colorado, United States, 80023|
|United States, Missouri|
|Clayton Sleep Institute|
|Maplewood, Missouri, United States, 63143|
|United States, New York|
|Sleep Medicine Centers|
|West Seneca, New York, United States, 14224|
|Study Chair:||Roger S Mecca, MD||Covidien|