Study to Predict the Need for Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence
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|ClinicalTrials.gov Identifier: NCT01517750|
Recruitment Status : Completed
First Posted : January 25, 2012
Results First Posted : June 24, 2015
Last Update Posted : June 24, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive||Device: ICON Auto CPAP™ with Thermosmart heated tube Device: ICON Auto CPAP™ without Thermosmart heated tube||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Experimental: APAP with humidification
ICON Auto CPAP™ with Thermosmart heated tube
Device: ICON Auto CPAP™ with Thermosmart heated tube
ICON Auto CPAP™ with heated humidification and the use of a heated tube
Active Comparator: APAP without humidification
ICON Auto CPAP™ without Thermosmart heated tube
Device: ICON Auto CPAP™ without Thermosmart heated tube
ICON Auto CPAP™ without heated humidification or the use of a heated tube.
- 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 ]
- Epworth Sleepiness Score (ESS) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517750
|Helios - Klinik Ambrock|
|Hagen, Weg, Germany, 60|
|Principal Investigator:||Georg Nilius, Dr.||Helios Klinik Ambrock|