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| ID | Type | Description | Link |
|---|---|---|---|
| 20081155 | Other Identifier | Western Institutional Review Board |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polysomnography (PSG) Subjects | Subjects who have been prescribed with needing a polysomnography (PSG) will be enrolled into the study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who are undergoing a standard sleep lab study/evaluation will have their data analyzed for this clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Roger S Mecca, MD | Medtronic - MITG | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SleepFit | Broomfield | Colorado | 80023 | United States | ||
| Clayton Sleep Institute |
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Patients were enrolled from 08/19/2008 to 10/14/2008 from 3 medical clinics in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Polysomnography (PSG) Subjects | Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Polysomnography (PSG) Subjects | Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | 90% Confidence Interval | Ratio | 9 Hours |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Polysomnography (PSG) Subjects | Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Clinical Affairs | Covidien | 303 305 2591 | Norma.Prince@Covidien.com |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| Maplewood |
| Missouri |
| 63143 |
| United States |
| Sleep Medicine Centers | West Seneca | New York | 14224 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| 0 |
| 92 |
| 0 |
| 92 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |