Trial Outcomes & Findings for Study to Predict the Need for Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence (NCT NCT01517750)
NCT ID: NCT01517750
Last Updated: 2015-06-24
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
6 weeks after patient randomization
Results posted on
2015-06-24
Participant Flow
Participant milestones
| Measure |
APAP Without Humidification + Low RIsks of NPC
ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems.
|
APAP With Humidification + Low Risks of NPC
ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems.
|
APAP With Humidification + High Risks of NPC
ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems.
|
APAP Without Humidification + High RIsks of NPC
ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
21
|
19
|
|
Overall Study
COMPLETED
|
20
|
17
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
4
|
1
|
Reasons for withdrawal
| Measure |
APAP Without Humidification + Low RIsks of NPC
ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems.
|
APAP With Humidification + Low Risks of NPC
ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems.
|
APAP With Humidification + High Risks of NPC
ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems.
|
APAP Without Humidification + High RIsks of NPC
ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
4
|
1
|
Baseline Characteristics
Study to Predict the Need for Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence
Baseline characteristics by cohort
| Measure |
APAP With Humidification + Low Risks of NPC
n=17 Participants
ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
|
APAP Without Humidification + Low RIsks of NPC
n=20 Participants
ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
|
APAP With Humidification + High Risks of NPC
n=17 Participants
ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
|
APAP Without Humidification + High Risks of NPC
n=18 Participants
ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
50.9 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
52.1 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
52.3 years
STANDARD_DEVIATION 8.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
17 participants
n=5 Participants
|
20 participants
n=7 Participants
|
17 participants
n=5 Participants
|
18 participants
n=4 Participants
|
72 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after patient randomizationOutcome measures
| Measure |
APAP With Humidification + Low Risks of NPC
n=17 Participants
ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
|
APAP Without Humidification + Low RIsks of NPC
n=20 Participants
ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
|
APAP With Humidification + High Risks of NPC
n=17 Participants
ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
|
APAP Without Humidification + High RIsks of NPC
n=18 Participants
ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
|
|---|---|---|---|---|
|
Therapy Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software With and Without Heated Humidification.
|
330 minutes
Standard Deviation 116
|
321 minutes
Standard Deviation 89
|
330 minutes
Standard Deviation 103
|
281 minutes
Standard Deviation 118
|
SECONDARY outcome
Timeframe: 6 weeks after patient randomizationThe ESS is a measure of daytime sleepiness and has a total of 24 points. A range from 0-9 is considered normal. A score of more than 9 is considered to have abnormal daytime sleepiness
Outcome measures
| Measure |
APAP With Humidification + Low Risks of NPC
n=17 Participants
ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
|
APAP Without Humidification + Low RIsks of NPC
n=20 Participants
ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
|
APAP With Humidification + High Risks of NPC
n=17 Participants
ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
|
APAP Without Humidification + High RIsks of NPC
n=18 Participants
ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
|
|---|---|---|---|---|
|
Epworth Sleepiness Score (ESS)
|
5.7 units on a scale
Standard Deviation 5.0
|
4.9 units on a scale
Standard Deviation 4.9
|
5.7 units on a scale
Standard Deviation 3.5
|
9.1 units on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 6 weeks after patient randomizationFOSQ is a measure of the impact of the disorder on multiple activities with everyday living and how the treatment can improve these activities. There are 30 questions and for each questions you have to pick from a subscale from 0-4; 0 = "I don't do this activity for other reasons", 1="Yes extremely", 2="Yes moderately", 3= "Yes a little", 4 = "No". Scores of each subscale will be summed up and scaled to a maximum achievable value of 20. The sum score was calculated. The value range is 0-100. A higher score means that the treatment has positively improved everyday activities.
Outcome measures
| Measure |
APAP With Humidification + Low Risks of NPC
n=17 Participants
ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
|
APAP Without Humidification + Low RIsks of NPC
n=20 Participants
ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
|
APAP With Humidification + High Risks of NPC
n=17 Participants
ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
|
APAP Without Humidification + High RIsks of NPC
n=18 Participants
ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
|
|---|---|---|---|---|
|
Functional Outcome of Sleep Questionnaire (FOSQ)
|
91.7 units on a scale
Standard Deviation 7.6
|
91.7 units on a scale
Standard Deviation 14.8
|
90.0 units on a scale
Standard Deviation 11.9
|
82.0 units on a scale
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 6 weeks after patient randomizationNasopharyngeal complaints (NPC) were assessed by a questionnaire. Subjects were asked to evaluate their condition on a scale from 0 ("no complaints") to 5 ("very strong"). The following questions were asked within the questionnaire: Did you observe nasal congestion, nasal dryness, runny nose, dry mouth, and dry throat (0-5 each) during the last week. The maximal achievable sum score was 25.
Outcome measures
| Measure |
APAP With Humidification + Low Risks of NPC
n=17 Participants
ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
|
APAP Without Humidification + Low RIsks of NPC
n=20 Participants
ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
|
APAP With Humidification + High Risks of NPC
n=17 Participants
ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
|
APAP Without Humidification + High RIsks of NPC
n=18 Participants
ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
|
|---|---|---|---|---|
|
Nasopharyngeal Complaints
|
4.4 units on a scale
Standard Deviation 4.4
|
7.3 units on a scale
Standard Deviation 3.1
|
5.4 units on a scale
Standard Deviation 3.0
|
10.7 units on a scale
Standard Deviation 6.6
|
POST_HOC outcome
Timeframe: 6 weeks after randomizationOutcome measures
| Measure |
APAP With Humidification + Low Risks of NPC
n=13 Participants
ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
|
APAP Without Humidification + Low RIsks of NPC
n=18 Participants
ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
|
APAP With Humidification + High Risks of NPC
n=21 Participants
ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
|
APAP Without Humidification + High RIsks of NPC
n=20 Participants
ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
|
|---|---|---|---|---|
|
Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries
NPC (Nasopharyngeal complaints)
|
5.0 units on a scale
Standard Deviation 4.7
|
10.8 units on a scale
Standard Deviation 6.1
|
4.9 units on a scale
Standard Deviation 3.0
|
7.5 units on a scale
Standard Deviation 4.2
|
|
Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries
ESS (Epworth sleepiness score)
|
5.3 units on a scale
Standard Deviation 5.7
|
8.1 units on a scale
Standard Deviation 4.9
|
5.5 units on a scale
Standard Deviation 3.2
|
6.5 units on a scale
Standard Deviation 4.7
|
|
Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries
FOSQ (Functional outcome of sleep questionnaire
|
90.9 units on a scale
Standard Deviation 15.9
|
85.5 units on a scale
Standard Deviation 12.1
|
90.9 units on a scale
Standard Deviation 11.5
|
88.5 units on a scale
Standard Deviation 10.1
|
POST_HOC outcome
Timeframe: 6 weeks after randomizationOutcome measures
| Measure |
APAP With Humidification + Low Risks of NPC
n=13 Participants
ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
|
APAP Without Humidification + Low RIsks of NPC
n=18 Participants
ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
|
APAP With Humidification + High Risks of NPC
n=21 Participants
ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
|
APAP Without Humidification + High RIsks of NPC
n=20 Participants
ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
|
|---|---|---|---|---|
|
Adherence With ENT Surgeries
|
327.9 mins
Standard Deviation 121.1
|
285.6 mins
Standard Deviation 124.6
|
331.5 mins
Standard Deviation 102.2
|
317.0 mins
Standard Deviation 82.8
|
Adverse Events
APAP With Humidification + Low Risks of NPC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
APAP Without Humidification + Low RIsks of NPC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
APAP With Humidification + High Risks of NPC
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
APAP Without Humidification + High RIsks of NPC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
APAP With Humidification + Low Risks of NPC
n=19 participants at risk
ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
|
APAP Without Humidification + Low RIsks of NPC
n=21 participants at risk
ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
|
APAP With Humidification + High Risks of NPC
n=21 participants at risk
ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
|
APAP Without Humidification + High RIsks of NPC
n=19 participants at risk
ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Hospitalization for Ureter Obstruction
|
0.00%
0/19
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/19
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place