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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-12-31

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.

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Detailed Description

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Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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APAP with humidification

ICON Auto CPAP™ with Thermosmart heated tube

Group Type EXPERIMENTAL

ICON Auto CPAP™ with Thermosmart heated tube

Intervention Type DEVICE

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

APAP without humidification

ICON Auto CPAP™ without Thermosmart heated tube

Group Type ACTIVE_COMPARATOR

ICON Auto CPAP™ without Thermosmart heated tube

Intervention Type DEVICE

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

Interventions

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ICON Auto CPAP™ with Thermosmart heated tube

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

Intervention Type DEVICE

ICON Auto CPAP™ without Thermosmart heated tube

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

Intervention Type DEVICE

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)