Sleep Apnea, Obstructive
Conditions
Keywords
Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure, ICON, ThermoSmart
Brief summary
Despite the effectiveness of continuous positive airway pressure (CPAP) in abolishing upper airway obstruction, acceptance of and adherence with therapy has been sub-optimal. One of the only technological advancements shown to increase adherence is heated humidification, now considered part of conventional CPAP therapy in some countries. ThermoSmart™ is a unique technology developed by Fisher & Paykel Healthcare which utilises a heated breathing tube to deliver optimal humidity in all environments. ThermoSmart has been shown to be superior to conventional humidification in reducing side effects, condensation and titrated pressure as well as increasing total sleep time. However, improved humidity delivery has not lead to significantly increased adherence in unselected obstructive sleep apnea (OSA) patients. A total of 80 patients diagnosed with OSA but naive to CPAP use will be randomized into a single blind, randomized, parallel-arm trial to determine whether the the use of heated humidification will impact therapy adherence.
Interventions
DEVICEICON Auto CPAP™ with Thermosmart heated tube
ICON Auto CPAP™ with heated humidification and the use of a heated tube
DEVICEICON Auto CPAP™ without Thermosmart heated tube
ICON Auto CPAP™ without heated humidification or the use of a heated tube.
Sponsors
Helios Klinik Ambrock
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with OSA * Naïve to CPAP therapy, i.e have not been prescribed, or used CPAP in the last 5 years * Prescribed a nasal mask (as patients will be prescribed their mask following recruitment into the study, any participants who are prescribed a full face mask will be withdrawn)
Exclusion criteria
* Severe heart disease * Co-existing lung disease * Co-existing sleep disorders * Pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 6 weeks after patient randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epworth Sleepiness Score (ESS) | 6 weeks after patient randomization | The 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 |
| Functional Outcome of Sleep Questionnaire (FOSQ) | 6 weeks after patient randomization | FOSQ 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. |
| Nasopharyngeal Complaints | 6 weeks after patient randomization | Nasopharyngeal 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| APAP With Humidification + Low Risks of NPC ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems. | 17 |
| APAP Without Humidification + Low RIsks of NPC ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems. | 20 |
| APAP With Humidification + High Risks of NPC ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems. | 17 |
| APAP Without Humidification + High Risks of NPC ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems. | 18 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 | 4 | 1 |
Baseline characteristics
| Characteristic | APAP With Humidification + Low Risks of NPC | APAP Without Humidification + Low RIsks of NPC | APAP With Humidification + High Risks of NPC | APAP Without Humidification + High Risks of NPC | Total |
|---|---|---|---|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 9.8 | 54.3 years STANDARD_DEVIATION 8.8 | 50.9 years STANDARD_DEVIATION 6.8 | 52.1 years STANDARD_DEVIATION 8.7 | 52.3 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment Germany | 17 participants | 20 participants | 17 participants | 18 participants | 72 participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 4 Participants | 4 Participants | 15 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 13 Participants | 14 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 21 | 0 / 21 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 | 1 / 21 | 0 / 19 |
Outcome results
Primary
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.
Time frame: 6 weeks after patient randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APAP With Humidification + Low Risks of NPC | 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 |
| APAP Without Humidification + Low RIsks of NPC | 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. | 321 minutes | Standard Deviation 89 |
| APAP With Humidification + High Risks of NPC | 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 103 |
| APAP Without Humidification + High RIsks of NPC | 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. | 281 minutes | Standard Deviation 118 |
Secondary
Epworth Sleepiness Score (ESS)
The 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
Time frame: 6 weeks after patient randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APAP With Humidification + Low Risks of NPC | Epworth Sleepiness Score (ESS) | 5.7 units on a scale | Standard Deviation 5 |
| APAP Without Humidification + Low RIsks of NPC | Epworth Sleepiness Score (ESS) | 4.9 units on a scale | Standard Deviation 4.9 |
| APAP With Humidification + High Risks of NPC | Epworth Sleepiness Score (ESS) | 5.7 units on a scale | Standard Deviation 3.5 |
| APAP Without Humidification + High RIsks of NPC | Epworth Sleepiness Score (ESS) | 9.1 units on a scale | Standard Deviation 3.9 |
Secondary
Functional Outcome of Sleep Questionnaire (FOSQ)
FOSQ 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.
Time frame: 6 weeks after patient randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APAP With Humidification + Low Risks of NPC | Functional Outcome of Sleep Questionnaire (FOSQ) | 91.7 units on a scale | Standard Deviation 7.6 |
| APAP Without Humidification + Low RIsks of NPC | Functional Outcome of Sleep Questionnaire (FOSQ) | 91.7 units on a scale | Standard Deviation 14.8 |
| APAP With Humidification + High Risks of NPC | Functional Outcome of Sleep Questionnaire (FOSQ) | 90.0 units on a scale | Standard Deviation 11.9 |
| APAP Without Humidification + High RIsks of NPC | Functional Outcome of Sleep Questionnaire (FOSQ) | 82.0 units on a scale | Standard Deviation 12 |
Secondary
Nasopharyngeal Complaints
Nasopharyngeal 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.
Time frame: 6 weeks after patient randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APAP With Humidification + Low Risks of NPC | Nasopharyngeal Complaints | 4.4 units on a scale | Standard Deviation 4.4 |
| APAP Without Humidification + Low RIsks of NPC | Nasopharyngeal Complaints | 7.3 units on a scale | Standard Deviation 3.1 |
| APAP With Humidification + High Risks of NPC | Nasopharyngeal Complaints | 5.4 units on a scale | Standard Deviation 3 |
| APAP Without Humidification + High RIsks of NPC | Nasopharyngeal Complaints | 10.7 units on a scale | Standard Deviation 6.6 |
Post Hoc
Adherence With ENT Surgeries
Time frame: 6 weeks after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APAP With Humidification + Low Risks of NPC | Adherence With ENT Surgeries | 327.9 mins | Standard Deviation 121.1 |
| APAP Without Humidification + Low RIsks of NPC | Adherence With ENT Surgeries | 285.6 mins | Standard Deviation 124.6 |
| APAP With Humidification + High Risks of NPC | Adherence With ENT Surgeries | 331.5 mins | Standard Deviation 102.2 |
| APAP Without Humidification + High RIsks of NPC | Adherence With ENT Surgeries | 317.0 mins | Standard Deviation 82.8 |
Post Hoc
Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries
Time frame: 6 weeks after randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APAP With Humidification + Low Risks of NPC | Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries | NPC (Nasopharyngeal complaints) | 5.0 units on a scale | Standard Deviation 4.7 |
| APAP With Humidification + Low Risks of NPC | 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 |
| APAP With Humidification + Low Risks of NPC | Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries | ESS (Epworth sleepiness score) | 5.3 units on a scale | Standard Deviation 5.7 |
| APAP Without Humidification + Low RIsks of NPC | Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries | NPC (Nasopharyngeal complaints) | 10.8 units on a scale | Standard Deviation 6.1 |
| APAP Without Humidification + Low RIsks of NPC | Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries | FOSQ (Functional outcome of sleep questionnaire | 85.5 units on a scale | Standard Deviation 12.1 |
| APAP Without Humidification + Low RIsks of NPC | Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries | ESS (Epworth sleepiness score) | 8.1 units on a scale | Standard Deviation 4.9 |
| APAP With Humidification + High Risks of NPC | Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries | ESS (Epworth sleepiness score) | 5.5 units on a scale | Standard Deviation 3.2 |
| APAP With Humidification + High Risks of NPC | Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries | NPC (Nasopharyngeal complaints) | 4.9 units on a scale | Standard Deviation 3 |
| APAP With Humidification + High Risks of NPC | Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries | FOSQ (Functional outcome of sleep questionnaire | 90.9 units on a scale | Standard Deviation 11.5 |
| APAP Without Humidification + High RIsks of NPC | Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries | NPC (Nasopharyngeal complaints) | 7.5 units on a scale | Standard Deviation 4.2 |
| APAP Without Humidification + High RIsks of NPC | Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries | FOSQ (Functional outcome of sleep questionnaire | 88.5 units on a scale | Standard Deviation 10.1 |
| APAP Without Humidification + High RIsks of NPC | Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries | ESS (Epworth sleepiness score) | 6.5 units on a scale | Standard Deviation 4.7 |