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

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.
ClinicalTrials.gov Identifier: NCT00775346
Recruitment Status : Completed
First Posted : October 20, 2008
Results First Posted : June 16, 2010
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Sleep-Disordered Breathing
Obstructive Sleep Apnea
Sleep Apnea
Central Sleep Apnea
Enrollment 92
Recruitment Details Patients were enrolled from 08/19/2008 to 10/14/2008 from 3 medical clinics in the United States.
Pre-assignment Details  
Arm/Group Title Polysomnography (PSG) Subjects
Hide Arm/Group Description Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
Period Title: Overall Study
Started 92
Completed 92
Not Completed 0
Arm/Group Title Polysomnography (PSG) Subjects
Hide Arm/Group Description Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
Overall Number of Baseline Participants 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
<=18 years
0
   0.0%
Between 18 and 65 years
76
  82.6%
>=65 years
16
  17.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants
52.7  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Female
41
  44.6%
Male
51
  55.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 92 participants
92
1.Primary Outcome
Title Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA).
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polysomnography (PSG) Subjects
Hide Arm/Group Description:
Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
Overall Number of Participants Analyzed 92
Mean (90% Confidence Interval)
Unit of Measure: Ratio
Sensitivity of Automated Assessment
0.820
(0.773 to 0.861)
Specificity of Automated Assessment
0.897
(0.883 to 0.910)
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Polysomnography (PSG) Subjects
Hide Arm/Group Description Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
All-Cause Mortality
Polysomnography (PSG) Subjects
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Polysomnography (PSG) Subjects
Affected / at Risk (%)
Total   0/92 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Polysomnography (PSG) Subjects
Affected / at Risk (%)
Total   0/92 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Manager, Clinical Affairs
Organization: Covidien
Phone: 303 305 2591
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