Study to Predict the Benefits of First-line Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-08-31

Brief Summary

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This study aims to investigate the benefits of using first line heated humidification. The primary objective of this research is to determine the effect of high levels of humidification delivered by ThermoSmart™ on CPAP adherence. In addition, to determine if it is possible to predict which patients benefit the most (i.e. be more adherent with therapy) from high levels of humidification delivered by ThermoSmart.

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Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Thermosmart

Subjects receive heated humidification

Group Type ACTIVE_COMPARATOR

Heated humidification (ThermoSmart)

Intervention Type DEVICE

Heated Humidification (ThermoSmart) Turned On

No humidification

Subjects use dry CPAP / APAP

Group Type PLACEBO_COMPARATOR

No Humidification

Intervention Type DEVICE

Heated Humidification (ThermoSmart) Turn Off

Interventions

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Heated humidification (ThermoSmart)

Heated Humidification (ThermoSmart) Turned On

Intervention Type DEVICE

No Humidification

Heated Humidification (ThermoSmart) Turn Off

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Older than 18 years of age
* Diagnosed with OSA and eligible for CPAP treatment under local requirements (AHI\>30 or if AHI is lower than 30, at least 10 micro arousals identified during diagnosis PSG).
* Naïve to CPAP therapy, i.e have not been prescribed, or used CPAP in the last 5 years
* Patients receiving social security coverage (excluding MEAs)
* Fluent spoken and written French