Trial Outcomes & Findings for Study to Predict the Benefits of First-line Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence (NCT NCT01742949)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

8 weeks

Results posted on

2019-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Thermosmart On, Then Followed by ThermoSmart Off Subjects receive heated humidification (ThermoSmart) first, then followed by it off.	ThermoSmart Off, Then Followed by ThermoSmart On Subjects receive dry CPAP/APAP (no ThermoSmart), then followed by it on.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=40 Participants All Participants as this is a crossover trial where participant will experience both heated humidification (ThermoSmart On) or dry CPAP/APAP (ThermoSmart Off)
Age, Continuous	62.3 years STANDARD_DEVIATION 9.379 • n=40 Participants
Sex: Female, Male Female	17 Participants n=40 Participants
Sex: Female, Male Male	23 Participants n=40 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Thermosmart n=40 Participants Subjects receive heated humidification Heated humidification (ThermoSmart): Heated Humidification (ThermoSmart) Turned On	No Humidification n=40 Participants Subjects use dry CPAP / APAP No Humidification: Heated Humidification (ThermoSmart) Turn Off	No Preference No Preference for ThermoSmart or no ThermoSmart
Adherence	4.7 hours per night Standard Deviation 2.7	5.0 hours per night Standard Deviation 2.5	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Thermosmart n=40 Participants Subjects receive heated humidification Heated humidification (ThermoSmart): Heated Humidification (ThermoSmart) Turned On	No Humidification n=40 Participants Subjects use dry CPAP / APAP No Humidification: Heated Humidification (ThermoSmart) Turn Off	No Preference No Preference for ThermoSmart or no ThermoSmart
Epworth Sleepiness Score	6.2 units on a scale Standard Deviation 0.8	6.0 units on a scale Standard Deviation 0.6	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Thermosmart n=40 Participants Subjects receive heated humidification Heated humidification (ThermoSmart): Heated Humidification (ThermoSmart) Turned On	No Humidification n=40 Participants Subjects use dry CPAP / APAP No Humidification: Heated Humidification (ThermoSmart) Turn Off	No Preference No Preference for ThermoSmart or no ThermoSmart
Short Functional Outcomes of Sleep Questionnaire (FOSQ-10)	32.1 units on a scale Standard Deviation 5.6	32 units on a scale Standard Deviation 6.2	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Thermosmart n=40 Participants Subjects receive heated humidification Heated humidification (ThermoSmart): Heated Humidification (ThermoSmart) Turned On	No Humidification n=40 Participants Subjects use dry CPAP / APAP No Humidification: Heated Humidification (ThermoSmart) Turn Off	No Preference No Preference for ThermoSmart or no ThermoSmart
Subjective Dry Nose	3.1 units on a scale Standard Deviation 3.6	4.8 units on a scale Standard Deviation 4.9	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Thermosmart n=40 Participants Subjects receive heated humidification Heated humidification (ThermoSmart): Heated Humidification (ThermoSmart) Turned On	No Humidification n=40 Participants Subjects use dry CPAP / APAP No Humidification: Heated Humidification (ThermoSmart) Turn Off	No Preference No Preference for ThermoSmart or no ThermoSmart
Subjective Dry Mouth	5.2 units on a scale Standard Deviation 4.9	6.7 units on a scale Standard Deviation 4.9	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Thermosmart n=40 Participants Subjects receive heated humidification Heated humidification (ThermoSmart): Heated Humidification (ThermoSmart) Turned On	No Humidification n=40 Participants Subjects use dry CPAP / APAP No Humidification: Heated Humidification (ThermoSmart) Turn Off	No Preference No Preference for ThermoSmart or no ThermoSmart
Subjective Sinusitis	1.8 units on a scale Standard Deviation 2.7	2.5 units on a scale Standard Deviation 3.6	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Thermosmart n=40 Participants Subjects receive heated humidification Heated humidification (ThermoSmart): Heated Humidification (ThermoSmart) Turned On	No Humidification n=40 Participants Subjects use dry CPAP / APAP No Humidification: Heated Humidification (ThermoSmart) Turn Off	No Preference n=40 Participants No Preference for ThermoSmart or no ThermoSmart
Preference	26 Participants	11 Participants	3 Participants

Adverse Events

Thermosmart

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Humidification

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Marie-Pia D'Ortho

Hopital Bichat-Claude Bernard

Phone: +33140258080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place