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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00775346
First Posted: October 20, 2008
Last Update Posted: August 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic - MITG
  Purpose
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.

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

Study Type: Observational
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.

Further study details as provided by Medtronic - MITG:

Primary Outcome Measures:
  • 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).


Enrollment: 92
Study Start Date: August 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Polysomnography (PSG) Subjects
Subjects who have been prescribed with needing a polysomnography (PSG) will be enrolled into the study.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Colorado
SleepFit
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
Sponsors and Collaborators
Medtronic - MITG
Investigators
Study Chair: Roger S Mecca, MD Medtronic - MITG
  More Information

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT00775346     History of Changes
Other Study ID Numbers: 04212008
20081155 ( Other Identifier: Western Institutional Review Board )
First Submitted: October 16, 2008
First Posted: October 20, 2008
Results First Submitted: March 15, 2010
Results First Posted: June 16, 2010
Last Update Posted: August 7, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Apnea, Central
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases