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There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SmartFlex | Experimental | Use Continuous Airway Pressure device with SmartFlex engaged |
|
| Standard | Active Comparator | Use Continuous Airway Pressure device without SmartFlex engaged |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmartFlex | Device | Device used with smartflex engaged. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypopnea Index (AHI) | Number of apnea/hypopnea events per hour, measured by SmartLink component of device. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Key Measures That Will be Used to Evaluate the Intervention(s) | The Epworth Sleepiness Scale will be used to evaluate sleepiness The Sleep Wake Activity Inventory will be used to evaluate sleepiness Daily diaries will be used to evaluate daily use of the device | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leon Rosenthal, MD | Sleep Medicine Associates of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Medicine Associates of Texas | Dallas | Texas | 75231 | United States | ||
| Sleep Therapy and Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | SmartFlex First, Then Standard | First two weeks with Smartflex engaged, second two weeks without Smartflex engaged |
| FG001 | Standard First, Then Smartflex | First two weeks without Smartflex engaged, second two weeks with Smartflex engaged |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Two-week Period |
| |||||||||||||
| Second Two-week Period |
|
Compliant participants completing study with evaluable results
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| ID | Title | Description |
|---|---|---|
| BG000 | All Evaluable Subjects | All subjects completing both two-week periods of crossover study, with evaluable results for each period. |
| 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 | Apnea-hypopnea Index (AHI) | Number of apnea/hypopnea events per hour, measured by SmartLink component of device. | Posted | Mean | Standard Deviation | events / hour | 4 weeks |
|
|
4 weeks
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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 | SmartFlex | CPAP device used with SmartFlex engaged, either in first or second two-week period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uncomfortable breathing due to expiratory resistance | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leon Rosenthal, MD | Sleep Medicine Associates of Texas | 214-750-7776 | LRosenthal@sleepmed.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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| ID | Term |
|---|---|
| D012015 | Reference Standards |
| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| D008919 | Investigative Techniques |
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| Standard | Device |
|
|
| San Antonio |
| Texas |
| 78229 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| AHI (apnea-hypopnea index) | Mean | Standard Deviation | events / hour |
|
| Participants |
|
|
| Secondary | Key Measures That Will be Used to Evaluate the Intervention(s) | The Epworth Sleepiness Scale will be used to evaluate sleepiness The Sleep Wake Activity Inventory will be used to evaluate sleepiness Daily diaries will be used to evaluate daily use of the device | Not Posted | 2 weeks |
| 0 |
| 17 |
| 4 |
| 17 |
| EG001 | Standard | CPAP device used without SmartFlex engaged, either in first or second two-week period. | 0 | 17 | 4 | 17 |
| EG002 | From data available it cannot be determined which mode the subject was using at the time of this event. | 0 | 17 | 1 | 17 |
| Mouth breathing which may worsen snoring or OSA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal, sinus or middle ear discomfort | Ear and labyrinth disorders | Systematic Assessment |
|
| Nose bleed | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dry mouth | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Redness on bridge of nose | General disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Hiatal hernia | General disorders | Non-systematic Assessment |
|
| Jaw pain | General disorders | Non-systematic Assessment |
|
| Pressure sore on bridge of nose | General disorders | Non-systematic Assessment |
|
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |