N/A
Completed N=80
Study to Predict the Need for Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence
Sleep Apnea, Obstructive
Source: ClinicalTrials.gov NCT01517750 ↗
Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Jun 2015
Primary outcomePrimary: 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; 321; 330; 281 minutes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
330; 321; 330; 281 | — |
| SECONDARY Epworth Sleepiness Score (ESS) |
5.7; 4.9; 5.7; 9.1 | — |
| SECONDARY Functional Outcome of Sleep Questionnaire (FOSQ) |
91.7; 91.7; 90.0; 82.0 | — |
| SECONDARY Nasopharyngeal Complaints |
4.4; 7.3; 5.4; 10.7 | — |
Eligibility Criteria
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their mask following recruitment into the study, any participants who are prescribed a full face mask will be withdrawn)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
Data sourced from ClinicalTrials.gov (NCT01517750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.