A Multi-Center Study to Assess the Performance of Saturation Patterns.

Completed

• Conditions: Sleep Apnea; Obstructive Sleep Apnea; Sleep-Disordered Breathing; Central Sleep Apnea

• Registration Number: NCT00775346
• Lead Sponsor: Medtronic - MITG

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Study First Submitted: 2008-10-16
• Study First Submitted QC: 2008-10-17
• Study First Posted: 2008-10-20
• Results First Submitted: 2010-03-15
• Results First Submitted QC: 2010-05-20
• Results First Posted: 2010-06-16
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Subjects will be referred to the Sleep Lab Center for evaluation of possible sleep-disordered breathing.
• Polysomnography (PSG) is obtained as part of normal, standard clinical practice.
• Subject is able to and willingly signs the informed consent form.

Exclusion Criteria

• Subject and/or parent/legal guardian is, in the opinion of the investigator, mentally and/or physically unable to provide informed consent/child assent and/or to complete all requirements of the protocol.
• Subject is currently participating in or has participated in an investigational drug study within seven (7) days of enrollment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA).	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).

Trial Locations

Locations (3)

Clayton Sleep Institute; 🇺🇸 Maplewood, Missouri, United States

SleepFit; 🇺🇸 Broomfield, Colorado, United States

Sleep Medicine Centers; 🇺🇸 West Seneca, New York, United States