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

This study has been completed.
Sponsor:
Information provided by:
Covidien
ClinicalTrials.gov Identifier:
NCT00775346
First received: October 16, 2008
Last updated: May 20, 2010
Last verified: May 2010
  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. 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.


Condition
Sleep-Disordered Breathing
Obstructive Sleep Apnea
Complex 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.

Resource links provided by NLM:


Further study details as provided by Covidien:

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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Covidien
Investigators
Study Chair: Roger S Mecca, MD Covidien
  More Information

No publications provided

Responsible Party: Norma Prince, Manager Clinical Affairs, Covidien
ClinicalTrials.gov Identifier: NCT00775346     History of Changes
Other Study ID Numbers: 04212008, 04212008, WIRB PRO NUM:20081155
Study First Received: October 16, 2008
Results First Received: March 15, 2010
Last Updated: May 20, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Respiratory Aspiration
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 Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014