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

Medtronic - MITG92 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Sleep-Disordered Breathing Obstructive Sleep Apnea Sleep Apnea Central Sleep Apnea

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

SleepFit

Broomfield, Colorado, United States

Clayton Sleep Institute

Maplewood, Missouri, United States

Sleep Medicine Centers

West Seneca, New York, United States

Outcomes

Primary Outcomes

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

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).

Time frame: 9 Hours

Data from ClinicalTrials.gov

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