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| Name | Class |
|---|---|
| Sleep Disorder Centers Institute for Clinical Research | UNKNOWN |
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Patients who have Obstructive Sleep Apnea (OSA) may have different Continuous Positive Airway Pressure (CPAP)when titrated with different levels of humidification. It is hypothesised that patients with ThermoSmart® technology (heated breathing tube technology) will have lower titrated pressures than those who are titrated using conventional humidification (non heated breathing tube).
Debate is present concerning the optimal level of humidification for obstructive sleep apnea (OSA) patients who need continuous positive airway pressure (CPAP) therapy. Recent evidence has shown that using a heated breathing tube to increase the amount of humidification that can be delivered has decreased patient side effects, increased subjective sleep quality and decreased subjective symptom scores. Anecdotal evidence exists, in the form of clinical observation, when ThermoSmart® technology is utilized during CPAP titration, patients laboratory titrated pressure may in fact prove to be lower. The possibility exists, on a titration night, patients potentially may experience an adverse response to the positive airway pressure which manifests as increased airway resistance and inflammation necessitating higher CPAP pressures to overcome upper airway resistance and flow limitation. Therefore, we hypothesize the delivery of higher levels of humidity might reduce the nasal airway resistance during the titration night, reducing the overall positive airway pressure requirements. The goal is to investigate this phenomenon to find if a reduction in pressure is necessary and if so to what degree. Patients who are titrated on Continuous Positive Airway Pressure devices with ThermoSmart® technology will have lower titrated pressures than those who are titrated using conventional humidification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Heated breathing tube |
|
| 2 | Active Comparator | Non heated breathing tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heated breathing tube (CPAP with ThermoSmart) | Device | CPAP with ThermoSmart - heated passover humidifier, with heated breathing tube |
|
| Measure | Description | Time Frame |
|---|---|---|
| Titration Pressures After Treatment Nights | Each night, the participant underwent a CPAP titration to determine their therapeutic pressure. During a titration, a sleep technician manually adjusts the participants pressure to determine which pressure is best for that individual in reducing their Apnea Hypopnea Index (AHI) which is the measure of Obstructive Sleep Apnea (OSA) severity. Titration pressures for each group were compared to see if there was any impact of having a heated breathing tube versus a non heated breathing tube on titration pressure. | End of titration night |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship Between the Intervention (Heated Breathing Tube vs Non Heated Breathing Tube) and Total Sleep Time | A correlation table was computed to explore the relationship between the intervention (heated breathing tube vs no heated breathing tube) and total sleep time. This relationship was calculated for each arm and reported by a Correlation Coefficient (r score). The r score represents the strength and direction of a relationship between two variables. The value of r is always between -1 and +1. Therefore, an r score of -1 indicates a perfect negative relationship between the intervention and total sleep time. An r score of -.50 indicates a moderate negative relationship between the intervention and total sleep time. An r score of 0 indicates no relationship between the intervention and total sleep time. An r score of +.50 indicates a moderate positive relationship between the intervention and total sleep time. An r score of +1 indicates a perfect positive relationship between the intervention and total sleep time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin L Lewis, M.D. | Sleep Disorder Centers Institute for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Center of Tulsa - Midtown | Tulsa | Oklahoma | 74135 | United States | ||
| Sleep Center of Tulsa - South |
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| Label | URL |
|---|---|
| Fisher \& Paykel Healthcare | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Heated Breathing Tube | Heated breathing tube (CPAP with ThermoSmart): CPAP with ThermoSmart - heated passover humidifier, with heated breathing tube |
| FG001 | Non Heated Breathing Tube |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Night 1 |
|
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| Non heated breathing tube (CPAP with conventional humidification) | Device | CPAP with conventional humidification - heated passover humidifier, no heated breathing tube |
|
|
| End of titration night |
| Tulsa |
| Oklahoma |
| 74137 |
| United States |
Non heated breathing tube (CPAP with conventional humidification): CPAP with conventional humidification - heated passover humidifier, no heated breathing tube
| COMPLETED |
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| NOT COMPLETED |
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| Night 2 (Crossover of Night 1) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All Study participants. Note: participants took part in both arms as it was a cross over trial |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Titration Pressures After Treatment Nights | Each night, the participant underwent a CPAP titration to determine their therapeutic pressure. During a titration, a sleep technician manually adjusts the participants pressure to determine which pressure is best for that individual in reducing their Apnea Hypopnea Index (AHI) which is the measure of Obstructive Sleep Apnea (OSA) severity. Titration pressures for each group were compared to see if there was any impact of having a heated breathing tube versus a non heated breathing tube on titration pressure. | Posted | Mean | Standard Deviation | cmH20 | End of titration night |
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| Secondary | Relationship Between the Intervention (Heated Breathing Tube vs Non Heated Breathing Tube) and Total Sleep Time | A correlation table was computed to explore the relationship between the intervention (heated breathing tube vs no heated breathing tube) and total sleep time. This relationship was calculated for each arm and reported by a Correlation Coefficient (r score). The r score represents the strength and direction of a relationship between two variables. The value of r is always between -1 and +1. Therefore, an r score of -1 indicates a perfect negative relationship between the intervention and total sleep time. An r score of -.50 indicates a moderate negative relationship between the intervention and total sleep time. An r score of 0 indicates no relationship between the intervention and total sleep time. An r score of +.50 indicates a moderate positive relationship between the intervention and total sleep time. An r score of +1 indicates a perfect positive relationship between the intervention and total sleep time. | Posted | Number | r score | End of titration night |
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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 | Heated Breathing Tube | Heated breathing tube (CPAP with ThermoSmart): CPAP with ThermoSmart - heated passover humidifier, with heated breathing tube | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | Non Heated Breathing Tube | Non heated breathing tube (CPAP with conventional humidification): CPAP with conventional humidification - heated passover humidifier, no heated breathing tube | 0 | 20 | 0 | 20 | 0 | 20 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hansinie Laing | Fisher & Paykel Healthcare | +64 9 574 0123 | 8601 | CPAP.TRIAL@fphcare.co.nz |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System 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 |
| D012138 | Respiratory Therapy |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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