Study to Predict the Need for Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence

Study Overview
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Brief Summary
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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.

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: ICON Auto CPAP™ with Thermosmart heated tube
* Device: ICON Auto CPAP™ without Thermosmart heated tube


Participation Criteria
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Eligibility Criteria
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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their mask following recruitment into the study, any participants who are prescribed a full face mask will be withdrawn) Exclusion Criteria: Severe heart disease Co-existing lung disease Co-existing sleep disorders Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APAP with humidification<br>ICON Auto CPAP™ with Thermosmart heated tube | Device: ICON Auto CPAP™ with Thermosmart heated tube<br>* ICON Auto CPAP™ with heated humidification and the use of a heated tube<br>|
| Active Comparator: APAP without humidification<br>ICON Auto CPAP™ without Thermosmart heated tube | Device: ICON Auto CPAP™ without Thermosmart heated tube<br>* ICON Auto CPAP™ without heated humidification or the use of a heated tube.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 weeks after patient randomization | 
| 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. | 6 weeks after patient randomization | 
| 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. | 6 weeks after patient randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure, ICON, ThermoSmart