NCT01517750

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DEVICE	ICON Auto CPAP™ with Thermosmart heated tube	ICON Auto CPAP™ with heated humidification and the use of a heated tube
DEVICE	ICON Auto CPAP™ without Thermosmart heated tube	ICON Auto CPAP™ without heated humidification or the use of a heated tube.

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-01-25
• Last updated: 2015-06-24
• Results posted: 2015-06-24

Locations

1 site across 1 country: Germany