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| Name | Class |
|---|---|
| Sibel Health Inc. | INDUSTRY |
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The main objective of this study is to evaluate the accuracy of the ANNE Sleep system for the diagnosis of obstructive sleep apnea (OSA) in adults
The main object of this study is to evaluate the accuracy of the ANNE Sleep system for the diagnosis of obstructive sleep apnea (OSA) in adults. Our primary hypothesis is that the ANNE Sleep system is non-inferior compared to polysomnography (PSG) for the diagnosis of obstructive sleep apnea
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Study | Other | After consent, subjects will wear the ANNE sleep system during an attended PSG study for 1 night. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANNE Sleep | Device | ANNE sleep system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography | The diagnosis of moderate to severe OSA by determining a patient's Apnea-Hypopnea Index (AHI) using the ANNE Sleep system compared to Polysomnography (PSG) over one (1) night worn concurrently. Sensitivity is the number of true positives divided by the sum of the number of true positives and false negatives. Specificity is the number of true negatives divided by the sum of the number of true negatives and false positives. | 1 night |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States | ||
| Northwestern Lake Forest Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35934926 | Derived | Davies C, Lee JY, Walter J, Kim D, Yu L, Park J, Blake S, Kalluri L, Cziraky M, Stanek E, Miller J, Harty BJ, Schauer J, Rangel SM, Serao A, Edel C, Ran DS, Olagbenro MO, Lim A, Gill K, Cooksey J, Toloui O, Power T, Xu S, Zee P. A single-arm, open-label, multicenter, and comparative study of the ANNE sleep system vs polysomnography to diagnose obstructive sleep apnea. J Clin Sleep Med. 2022 Dec 1;18(12):2703-2712. doi: 10.5664/jcsm.10194. |
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Data stored and used for future research will be de-identified. Data will not be used for future research outside of the scope of this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | ANNE Sleep System | After consent, subjects will wear the ANNE sleep system during an attended PSG study for 1 night. ANNE Sleep: ANNE sleep system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Study | After consent, subjects will wear the ANNE sleep system during an attended PSG study for 1 night. ANNE Sleep: ANNE sleep system |
| 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 of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography | The diagnosis of moderate to severe OSA by determining a patient's Apnea-Hypopnea Index (AHI) using the ANNE Sleep system compared to Polysomnography (PSG) over one (1) night worn concurrently. Sensitivity is the number of true positives divided by the sum of the number of true positives and false negatives. Specificity is the number of true negatives divided by the sum of the number of true negatives and false positives. | Posted | Mean | 95% Confidence Interval | percentage of true cases | 1 night |
|
One night of sleep.
Subjects wear the ANNE Sleep device concurrently with the gold standard polysomnography over one night of sleep.
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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 | Single Arm Study | After consent, subjects will wear the ANNE sleep system during an attended PSG study for 1 night. ANNE Sleep: ANNE sleep system |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phyllis Zee, MD | Northwestern University | 312-503-5944 | SleepSensors@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2021 | Nov 15, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 13, 2021 | Nov 15, 2022 | ICF_001.pdf |
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Patients will use ANNE Sleep system during one night of polysomnography recording in sleep lab.
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| Lake Forest |
| Illinois |
| 60045 |
| United States |
| Carle Foundation Hosipital | Urbana | Illinois | 61801 | United States |
| Central Dupage Hospital (CDH) | Winfield | Illinois | 60190 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 225 |
| 0 |
| 225 |
| 0 |
| 225 |
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