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This study aims to investigate the benefits of using first line heated humidification. The primary objective of this research is to determine the effect of high levels of humidification delivered by ThermoSmart™ on CPAP adherence. In addition, to determine if it is possible to predict which patients benefit the most (i.e. be more adherent with therapy) from high levels of humidification delivered by ThermoSmart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermosmart | Active Comparator | Subjects receive heated humidification |
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| No humidification | Placebo Comparator | Subjects use dry CPAP / APAP |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heated humidification (ThermoSmart) | Device | Heated Humidification (ThermoSmart) Turned On |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Adherence with treatment per night averaged over total time period measured via internal software on the CPAP device and reported using InfoSmart™ software. The report will include all the supporting information recorded within the CPAP device. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Epworth Sleepiness Score | Subjective measure of daytime sleepiness. There are 8 questions where the patient picks a scale of 0 = would never doze to 3 = high level of dozing for each questions. There can be a total score of 24. A score of 0-10 indicates normal daytime sleepiness, 11-12 mild excessive daytime sleepiness, 13-15 moderate excessive daytime sleepiness and 16-24 is severe excessive daytime sleepiness. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Pia D'Dortho, MD | Hôpital Bichat-Claude Bernard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Bichat-Claude Bernard | Paris | Paris Cedex | 75877 | France | ||
| Hôpital Henri Mondor |
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| ID | Title | Description |
|---|---|---|
| FG000 | Thermosmart On, Then Followed by ThermoSmart Off | Subjects receive heated humidification (ThermoSmart) first, then followed by it off. |
| FG001 | ThermoSmart Off, Then Followed by ThermoSmart On |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| No Humidification |
| Device |
Heated Humidification (ThermoSmart) Turn Off |
|
| 8 weeks |
| Short Functional Outcomes of Sleep Questionnaire (FOSQ-10) | Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life. | 8 weeks |
| Subjective Dry Nose | Measured through a visual analog scale. The patient has to mark a cross on the scale to indicate the severity of their symptoms. On the left side of the scale has "not at all" and on the right side of the scale has "extremely", In order to analyze the data, a ruler from the start of the scale (Left side) to the middle of the cross is measured in cm. The total length of the scale is 14 cm. Therefore, the minimum score is 0 and the maximum score is 14. The higher the score means that the participant is experiencing more symptoms. | 8 weeks |
| Subjective Dry Mouth | Measured through a visual analog scale. The patient has to mark a cross on the scale to indicate the severity of their symptoms. On the left side of the scale has "not at all" and on the right side of the scale has "extremely", In order to analyze the data, a ruler from the start of the scale (Left side) to the middle of the cross is measured in cm. The total length of the scale is 14 cm. Therefore, the minimum score is 0 and the maximum score is 14. The higher the score means that the participant is experiencing more symptoms. | 8 weeks |
| Subjective Sinusitis | Measured through a visual analog scale. The patient has to mark a cross on the scale to indicate the severity of their symptoms. On the left side of the scale has "not at all" and on the right side of the scale has "extremely", In order to analyze the data, a ruler from the start of the scale (Left side) to the middle of the cross is measured in cm. The total length of the scale is 14 cm. Therefore, the minimum score is 0 and the maximum score is 14. The higher the score means that the participant is experiencing more symptoms. | 8 weeks |
| Preference | Through a questionnaire, the participant is asked to picked rather they prefer treatment A (No ThermoSmart) or treatment B (ThermoSmart). If they did not pick neither, it is considered no preference. | 8 weeks |
| Paris |
| France |
| Hôpital La Pitie Salpetriere | Paris | France |
| Hôpital Louis Mourier | Paris | France |
Subjects receive dry CPAP/APAP (no ThermoSmart), then followed by it on.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All Participants as this is a crossover trial where participant will experience both heated humidification (ThermoSmart On) or dry CPAP/APAP (ThermoSmart Off) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| 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 | Adherence | Adherence with treatment per night averaged over total time period measured via internal software on the CPAP device and reported using InfoSmart™ software. The report will include all the supporting information recorded within the CPAP device. | Posted | Mean | Standard Deviation | hours per night | 8 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Epworth Sleepiness Score | Subjective measure of daytime sleepiness. There are 8 questions where the patient picks a scale of 0 = would never doze to 3 = high level of dozing for each questions. There can be a total score of 24. A score of 0-10 indicates normal daytime sleepiness, 11-12 mild excessive daytime sleepiness, 13-15 moderate excessive daytime sleepiness and 16-24 is severe excessive daytime sleepiness. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Short Functional Outcomes of Sleep Questionnaire (FOSQ-10) | Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Subjective Dry Nose | Measured through a visual analog scale. The patient has to mark a cross on the scale to indicate the severity of their symptoms. On the left side of the scale has "not at all" and on the right side of the scale has "extremely", In order to analyze the data, a ruler from the start of the scale (Left side) to the middle of the cross is measured in cm. The total length of the scale is 14 cm. Therefore, the minimum score is 0 and the maximum score is 14. The higher the score means that the participant is experiencing more symptoms. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Subjective Dry Mouth | Measured through a visual analog scale. The patient has to mark a cross on the scale to indicate the severity of their symptoms. On the left side of the scale has "not at all" and on the right side of the scale has "extremely", In order to analyze the data, a ruler from the start of the scale (Left side) to the middle of the cross is measured in cm. The total length of the scale is 14 cm. Therefore, the minimum score is 0 and the maximum score is 14. The higher the score means that the participant is experiencing more symptoms. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Subjective Sinusitis | Measured through a visual analog scale. The patient has to mark a cross on the scale to indicate the severity of their symptoms. On the left side of the scale has "not at all" and on the right side of the scale has "extremely", In order to analyze the data, a ruler from the start of the scale (Left side) to the middle of the cross is measured in cm. The total length of the scale is 14 cm. Therefore, the minimum score is 0 and the maximum score is 14. The higher the score means that the participant is experiencing more symptoms. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Preference | Through a questionnaire, the participant is asked to picked rather they prefer treatment A (No ThermoSmart) or treatment B (ThermoSmart). If they did not pick neither, it is considered no preference. | Posted | Count of Participants | Participants | 8 weeks |
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10 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 | Thermosmart | Subjects receive heated humidification Heated humidification (ThermoSmart): Heated Humidification (ThermoSmart) Turned On | 0 | 40 | 0 | 40 | 0 | 40 |
| EG001 | No Humidification | Subjects use dry CPAP / APAP No Humidification: Heated Humidification (ThermoSmart) Turn Off | 0 | 40 | 0 | 40 | 0 | 40 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Marie-Pia D'Ortho | Hopital Bichat-Claude Bernard | +33140258080 | marie-pia.dortho@bch.aphp.fr |
| 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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