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| Name | Class |
|---|---|
| Suburban Lung Associates | OTHER |
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That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP with ThermoSmart, then CPAP without ThermoSmart | Experimental | CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube. CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube. |
|
| CPAP without ThermoSmart, then CPAP with ThermoSmart | Experimental | CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube. CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP with ThermoSmart, then CPAP without ThermoSmart | Device | CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube. CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube. |
| Measure | Description | Time Frame |
|---|---|---|
| CPAP Compliance | 1, 4 & 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective & Objective Sleep Parameters | 1, 4 & 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clifford A Massie, PhD | Suburban Lung Asssociates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suburban Lung Associates | Chicago | Illinois | 60007 | United States |
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| Label | URL |
|---|---|
| Fisher \& Paykel Healthcare | View source |
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All data from this trial has been lost This includes all case report forms and consent forms and therefore, there are no results to report as no data exists
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| ID | Title | Description |
|---|---|---|
| FG000 | CPAP With ThermoSmart, Then CPAP Without ThermoSmart | CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube. CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube. |
| FG001 | CPAP Without ThermoSmart, Then CPAP With ThermoSmart | CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube. CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All data from this trial has been lost. This includes all case report forms and consent forms and therefore, there are no results to report as no data exists.
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| ID | Title | Description |
|---|---|---|
| BG000 | CPAP With ThermoSmart, Then CPAP Without ThermoSmart | CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube. CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube. |
| BG001 | CPAP Without ThermoSmart, Then CPAP With ThermoSmart |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | CPAP Compliance | All data from this trial has been lost This includes all case report forms and consent forms and therefore, there are no results to report as no data exists | Posted | 1, 4 & 8 weeks |
|
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All data for this trial has been lost. All case report forms and consent forms were lost and therefore, there are no results to report as no data exists.
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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 | CPAP With ThermoSmart, Then CPAP Without ThermoSmart | CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube. CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | Fisher and Paykel Healthcare | +64 09 574 0100 | 7044 | CPAP.trial@fphcare.co.nz |
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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 |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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|
|
| CPAP without ThermoSmart, then CPAP with ThermoSmart | Device | CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube. CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube. |
|
|
CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube. CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube. |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
|
| Secondary | Subjective & Objective Sleep Parameters | All data from this trial has been lost. This includes all case report forms and consent forms and therefore, there are no results to report as no data exists | Posted | 1, 4 & 8 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | CPAP Without ThermoSmart, Then CPAP With ThermoSmart | CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube. CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |