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The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficient of r=0.75 indicating strong correlation between the AHI of diagnostic PSG and AL.
All subjects with suspected Sleep Disordered Breathing (SDB) scheduled for diagnostic polysomnography (PSG) will be invited to participate in the study to be tested to determine if they have Sleep Disordered Breathing (SDB), using the ApneaLink (AL) Sleep Screener. Subjects initially will be tested for SDB in the home environment. Following an AL home test, subjects will undergo a simultaneous, attended diagnostic polysomnography (PSG) sleep study and ApneaLink test for the purpose of confirming and comparing the results between diagnostic PSG and the AL device.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ApneaLink Sleep Screener | Device | Device used to evaluate for the presence of OSA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity | Comparison of sensitivity and specificity of ApneaLink to polysomnography with an apnea hypopnea index (AHI) cut-off of 15 or greater | Simultaneous single night recording |
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Inclusion Criteria:
Exclusion Criteria:
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Pts. with suspected OSA.
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| Name | Affiliation | Role |
|---|---|---|
| Patrick J Strollo, MD | Associate Professor of medicine and Medical Director, UPMC Sleep Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21897775 | Derived | Oktay B, Rice TB, Atwood CW Jr, Passero M Jr, Gupta N, Givelber R, Drumheller OJ, Houck P, Gordon N, Strollo PJ Jr. Evaluation of a single-channel portable monitor for the diagnosis of obstructive sleep apnea. J Clin Sleep Med. 2011 Aug 15;7(4):384-90. doi: 10.5664/JCSM.1196. |
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There is no plan to share IPD.
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| ID | Title | Description |
|---|---|---|
| FG000 | Suspicion of Obstructive Sleep Apnea | Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Suspicion of Obstructive Sleep Apnea | Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Comparison of sensitivity and specificity of ApneaLink to polysomnography with an apnea hypopnea index (AHI) cut-off of 15 or greater | Posted | Number | percentage | Simultaneous single night recording |
|
|
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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 | Suspicion of Obstructive Sleep Apnea | Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Medical Affairs | ResMed | 858 836 6782 | ResmedScienceCenter@resmed.com.au |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
|
| 0 |
| 53 |
| 0 |
| 53 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |