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To study the effects of two combination therapies for patients with obstructive sleep apnea (OSA) who have been both intolerant to Positive Airway Pressure (PAP) therapy and sub-therapeutic to oral appliance therapy.
Hypothesis
1. There is a difference between Continuous Positive Airway Pressure (CPAP) vs CPAP/Oral Appliance (OA) connect vs CPAP/OA disconnected in terms of:
2. There is a difference between connected and disconnected for the following symptoms:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Therapy with Preferred Mask | Experimental | Preferred Mask refers to a type of existing medical mask used for PAP therapy. |
|
| Combination Therapy with Custom Mask | Experimental | Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nuance Pro | Device | Study compares Nuance Pro plus Automatic Positive Airway Pressure (autoPAP) vs TAP PAP plus autoPAP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea Index | Episodes per hour that the patient experiences apneas and/or hypopneas | 2 months |
| PAP Pressure | The pressure required to treat the patient successfully | 2 months |
| Leaks | The Liters/Minute of leaking of the PAP machine | 2 months |
| Hours of Use | The average hours of use per night of each of the combination therapies | 2 months |
| Epworth Sleepiness Scale (ESS) | The ESS is a self-administered questionnaire with 8 questions. The score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life. | 2 months |
| Functional Outcomes Sleep Questionnaire (FOSQ) | FOSQ is a disease specific quality of life questionnaire to determine how sleepiness interferes one's quality of life. The total score range from 5 to 20 (10 questions, 1-4 points per each). The lower values represent a worse quality of life. | 2 months |
| Intolerance Questionnaire | This questionnaire consists of 4 questions to determine the frequency of 4 typical side-effects from positive airway pressure therapy. The score ranges from 0 to 16 (4 questions, 0-4 points per each). The higher value represent worse side effects. |
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Inclusion Criteria: Baseline diagnosis AHI > or = 5 plus ESS . or = 10.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| J. Michael Adame, DDS, PA | Edinburg | Texas | 78539 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combination Therapy With Preferred Mask | Preferred Mask refers to a type of existing medical mask used for Positive Airway Pressure (PAP) therapy. Nuance Pro: Study compares Nuance Pro plus Automatic Positive Airway (autoPAP ) vs TAP PAP plus autoPAP autoPAP: autoPAP |
| FG001 | Combination Therapy With Custom Mask | Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance. autoPAP: autoPAP TAP PAP: TAP PAP |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Combination Therapy With Preferred Mask | Preferred Mask refers to a type of existing medical mask used for PAP therapy. Nuance Pro: Study compares Nuance Pro plus autoPAP vs TAP PAP plus autoPAP autoPAP: autoPAP |
| BG001 | Combination Therapy With Custom Mask |
| 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 | Apnea-Hypopnea Index | Episodes per hour that the patient experiences apneas and/or hypopneas | Missing data from 1 participant in Combination Therapy with Preferred Mask group | Posted | Mean | Standard Deviation | episodes/hour | 2 months |
|
2 months
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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 | Combination Therapy With Preferred Mask | Preferred Mask refers to a type of existing medical mask used for PAP therapy. Nuance Pro: Study compares Nuance Pro plus autoPAP vs TAP PAP plus autoPAP autoPAP: autoPAP |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yasue Tanaka | Tohoku University | +81227178396 | yasue.tanaka.b3@tohoku.ac.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 16, 2015 | Mar 8, 2021 | Prot_SAP_ICF_001.pdf |
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| autoPAP | Device | autoPAP |
|
| TAP PAP | Device | TAP PAP |
|
| 2 months |
Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance. autoPAP: autoPAP TAP PAP: TAP PAP |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Primary | PAP Pressure | The pressure required to treat the patient successfully | Missing data from 1 participant in Combination Therapy with Preferred Mask group. | Posted | Mean | Standard Deviation | cmH2O | 2 months |
|
|
|
| Primary | Leaks | The Liters/Minute of leaking of the PAP machine | Missing data from 1 participant in Combination Therapy with Preferred Mask group. | Posted | Mean | Standard Deviation | L/min | 2 months |
|
|
|
| Primary | Hours of Use | The average hours of use per night of each of the combination therapies | Missing data from 1 participant in Combination Therapy with Preferred Mask group. | Posted | Mean | Standard Deviation | hours per night | 2 months |
|
|
|
| Primary | Epworth Sleepiness Scale (ESS) | The ESS is a self-administered questionnaire with 8 questions. The score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life. | Missing data from 1 participant in Combination Therapy with Preferred Mask group. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
|
|
|
| Primary | Functional Outcomes Sleep Questionnaire (FOSQ) | FOSQ is a disease specific quality of life questionnaire to determine how sleepiness interferes one's quality of life. The total score range from 5 to 20 (10 questions, 1-4 points per each). The lower values represent a worse quality of life. | Missing data from 1 participant in Combination Therapy with Preferred Mask group. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
|
|
|
| Primary | Intolerance Questionnaire | This questionnaire consists of 4 questions to determine the frequency of 4 typical side-effects from positive airway pressure therapy. The score ranges from 0 to 16 (4 questions, 0-4 points per each). The higher value represent worse side effects. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Combination Therapy With Custom Mask | Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance. autoPAP: autoPAP TAP PAP: TAP PAP | 0 | 13 | 0 | 13 | 0 | 13 |
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