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The purpose of this protocol is to improve the current FDA-approved continuous positive pressure auto-titration algorithm, including treatment precision, residual disease detection characteristics and phenotyping with the DeVilbiss brand AutoAdjust CPAP device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental | All subjects underwent a sleep study with DeVilbiss AutoAdjust CPAP with revised algorithm simultaneously with hand-scored PSG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DeVilbiss AutoAdjust CPAP with revised algorithm | Device | Subjects attended a one-night polysomnogram (PSG) titration study. DeVilbiss AutoAdjust CPAP with a revised algorithm was compared to hand-scored PSG to determine whether the machine results were equivalent to hand scores. Each subject acted as their own control for assessing accuracy of sleep event analysis and prescribed CPAP pressure. |
| Measure | Description | Time Frame |
|---|---|---|
| % Agreement Between Reviewer and Machine Pressure Settings During Sleep Study | The primary objective for the study was demonstrating effectiveness of therapy provided by the DeVilbiss AutoAdjust device as reported by the expert human reviewer. The primary endpoint was that expert human reviewer should agree with pressure changes made by the machine during each 20-minute epoch at least 80% of the time. Expert human reviewer reviewed each study and made a determination at 20-minute time points, in context of REM/NON-REM sleep and supine/non-supine positions, marking the machine pressure response with an "agree" or "disagree." Pressure changes might show no change, increase or decrease during the 20-minute epoch. | 1 night |
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Inclusion Criteria:
Exclusion Criteria:
Diagnosis of mild sleep apnea
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NeuroCare, Inc. | Newton | Massachusetts | 02459 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | All enrolled subjects |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects completing the study with evaluable results
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| ID | Title | Description |
|---|---|---|
| BG000 | All Evaluable Subjects | All subjects completing the one-night sleep study with evaluable results. |
| 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 | % Agreement Between Reviewer and Machine Pressure Settings During Sleep Study | The primary objective for the study was demonstrating effectiveness of therapy provided by the DeVilbiss AutoAdjust device as reported by the expert human reviewer. The primary endpoint was that expert human reviewer should agree with pressure changes made by the machine during each 20-minute epoch at least 80% of the time. Expert human reviewer reviewed each study and made a determination at 20-minute time points, in context of REM/NON-REM sleep and supine/non-supine positions, marking the machine pressure response with an "agree" or "disagree." Pressure changes might show no change, increase or decrease during the 20-minute epoch. | Subjects completing the study with evaluable results | Posted | Number | 95% Confidence Interval | percentage of agreement | 1 night |
|
Adverse events were assessed for the period from patient's enrollment in the study up to termination (the morning following the one-night sleep study).
Adverse events were assessed per a list of probable events associated with use of CPAP equipment. There were no adverse events for the analysis population.
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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 | Evaluable Subjects | All subjects completing the one-night sleep study with evaluable results. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jim Froehlich | DeVilbiss Healthcare | 814-443-7692 | Jim.Froehlich@devilbisshc.com |
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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 |
|
| Apnea Type at Enrollment | Number of participants with obstructive vs central apnea at enrollment | Number | participants |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |