A Multi-Center Study to Assess the Performance of Saturation Patterns.
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|ClinicalTrials.gov Identifier: NCT00775346|
Recruitment Status : Completed
First Posted : October 20, 2008
Results First Posted : June 16, 2010
Last Update Posted : August 7, 2014
|Condition or disease|
|Sleep-Disordered Breathing Obstructive Sleep Apnea Sleep Apnea Central Sleep Apnea|
|Study Type :||Observational|
|Actual Enrollment :||92 participants|
|Official Title:||A Multi-Center Study to Assess the Performance of the Saturation Pattern Detection (SPD) Software Algorithm.|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
Polysomnography (PSG) Subjects
Subjects who have been prescribed with needing a polysomnography (PSG) will be enrolled into the study.
- Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA). [ Time Frame: 9 Hours ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775346
|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||Medtronic - MITG|