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

August 5, 2014 updated by: Medtronic - MITG

A Multi-Center Study to Assess the Performance of the Saturation Pattern Detection (SPD) Software Algorithm.

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Broomfield, Colorado, United States, 80023
        • SleepFit
    • Missouri
      • Maplewood, Missouri, United States, 63143
        • Clayton Sleep Institute
    • New York
      • West Seneca, New York, United States, 14224
        • Sleep Medicine Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who are undergoing a standard sleep lab study/evaluation will have their data analyzed for this clinical trial.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Polysomnography (PSG) Subjects
Subjects who have been prescribed with needing a polysomnography (PSG) will be enrolled into the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
9 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Investigators

  • Study Chair: Roger S Mecca, MD, Medtronic - MITG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

October 16, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (Estimate)

October 20, 2008

Study Record Updates

Last Update Posted (Estimate)

August 7, 2014

Last Update Submitted That Met QC Criteria

August 5, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04212008
  • 20081155 (Other Identifier: Western Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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