Obstructive Sleep Apnea
Conditions
Brief summary
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.
Interventions
DEVICEHeated humidification (ThermoSmart)
Heated Humidification (ThermoSmart) Turned On
DEVICENo Humidification
Heated Humidification (ThermoSmart) Turn Off
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Older than 18 years of age * Diagnosed with OSA and eligible for CPAP treatment under local requirements (AHI\>30 or if AHI is lower than 30, at least 10 micro arousals identified during diagnosis PSG). * Naïve to CPAP therapy, i.e have not been prescribed, or used CPAP in the last 5 years * Patients receiving social security coverage (excluding MEAs) * Fluent spoken and written French
Exclusion criteria
* Severe heart disease * Co-existing lung disease * Co-existing sleep disorder * Pregnant * Refused participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Functional Outcomes of Sleep Questionnaire (FOSQ-10) | 8 weeks | 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. |
| Subjective Dry Nose | 8 weeks | 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. |
| Epworth Sleepiness Score | 8 weeks | 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. |
| Subjective Sinusitis | 8 weeks | 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. |
| Preference | 8 weeks | 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. |
| Subjective Dry Mouth | 8 weeks | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 9.379 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 23 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermosmart | Adherence | 4.7 hours per night | Standard Deviation 2.7 |
| No Humidification | Adherence | 5.0 hours per night | Standard Deviation 2.5 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermosmart | Epworth Sleepiness Score | 6.2 units on a scale | Standard Deviation 0.8 |
| No Humidification | Epworth Sleepiness Score | 6.0 units on a scale | Standard Deviation 0.6 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thermosmart | Preference | 26 Participants |
| No Humidification | Preference | 11 Participants |
| No Preference | Preference | 3 Participants |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermosmart | Short Functional Outcomes of Sleep Questionnaire (FOSQ-10) | 32.1 units on a scale | Standard Deviation 5.6 |
| No Humidification | Short Functional Outcomes of Sleep Questionnaire (FOSQ-10) | 32 units on a scale | Standard Deviation 6.2 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermosmart | Subjective Dry Mouth | 5.2 units on a scale | Standard Deviation 4.9 |
| No Humidification | Subjective Dry Mouth | 6.7 units on a scale | Standard Deviation 4.9 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermosmart | Subjective Dry Nose | 3.1 units on a scale | Standard Deviation 3.6 |
| No Humidification | Subjective Dry Nose | 4.8 units on a scale | Standard Deviation 4.9 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermosmart | Subjective Sinusitis | 1.8 units on a scale | Standard Deviation 2.7 |
| No Humidification | Subjective Sinusitis | 2.5 units on a scale | Standard Deviation 3.6 |