A Multi-Center Study to Assess the Performance of Saturation Patterns.
This study has been completed.
Sponsor:
Covidien
Information provided by:
Covidien
ClinicalTrials.gov Identifier:
NCT00775346
First received: October 16, 2008
Last updated: May 20, 2010
Last verified: May 2010
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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
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 May 21, 2013