Trial Outcomes & Findings for A Multi-Center Study to Assess the Performance of Saturation Patterns. (NCT NCT00775346)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

92 participants

Primary outcome timeframe

9 Hours

Results posted on

2014-08-07

Participant Flow

Patients were enrolled from 08/19/2008 to 10/14/2008 from 3 medical clinics in the United States.

Participant milestones

Participant milestones
Measure	Polysomnography (PSG) Subjects Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
Overall Study STARTED	92
Overall Study COMPLETED	92
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Polysomnography (PSG) Subjects n=92 Participants Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	76 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Age, Continuous	52.7 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Region of Enrollment United States	92 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Polysomnography (PSG) Subjects n=92 Participants Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA). Sensitivity of Automated Assessment	0.820 Ratio Interval 0.773 to 0.861
Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA). Specificity of Automated Assessment	0.897 Ratio Interval 0.883 to 0.91

Adverse Events

Polysomnography (PSG) Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Clinical Affairs

Covidien

Phone: 303 305 2591

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER