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

NCT00775346 | Completed Results

• 2 other identifiers: 0421200820081155
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Sleep-Disordered Breathing; Obstructive Sleep Apnea; Sleep Apnea; Central Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Polysomnography (PSG) Subjects

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (3)

SleepFit

Broomfield, Colorado, 80023, United States

Location

Clayton Sleep Institute

Maplewood, Missouri, 63143, United States

Location

Sleep Medicine Centers

West Seneca, New York, 14224, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Manager, Clinical Affairs
• Organization: Covidien

Norma.Prince@Covidien.com

303 305 2591

Study Officials

• Roger S Mecca, MD

  Medtronic - MITG

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 20, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 7, 2014
• Results First Posted: June 16, 2010

Record last verified: 2014-08

Locations

US (3)