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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00775346
• Other study ID #: 04212008
• Secondary ID: 20081155
• Status: Completed
• Phase: N/A
• First received: October 16, 2008
• Last updated: August 5, 2014
• Start date: August 2008
• Est. completion date: October 2008

Study information

• Verified date: August 2014
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apnea
• Obstructive Sleep Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep-Disordered Breathing

Locations

Country	Name	City	State
United States	SleepFit	Broomfield	Colorado
United States	Clayton Sleep Institute	Maplewood	Missouri
United States	Sleep Medicine Centers	West Seneca	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	9 Hours	No