CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
ICON Auto CPAP™ with Thermosmart heated tube +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01517750
NCT01517750N/ACompleted

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

Fisher and Paykel Healthcare·interventional·Posted Jan 25, 2012·Updated Jun 24, 2015

In Brief

A clinical study evaluating ICON Auto CPAP™ with Thermosmart heated tube and ICON Auto CPAP™ without Thermosmart heated tube for Sleep Apnea, Obstructive. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2012
Enrollment StartJan 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.4 years ago

Interventions

ICON Auto CPAP™ with Thermosmart heated tubedevice

ICON Auto CPAP™ with heated humidification and the use of a heated tube

ICON Auto CPAP™ without Thermosmart heated tubedevice

ICON Auto CPAP™ without heated humidification or the use of a heated tube.