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

Fisher & Paykel Healthcare

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: No Humidification; Device: Heated humidification (ThermoSmart)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01742949

FPH-TS2012

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Severe heart disease
• Co-existing lung disease
• Co-existing sleep disorder
• Pregnant
• Refused participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Thermosmart

Active Comparator group

Description:

Subjects receive heated humidification

Treatment:

Device: Heated humidification (ThermoSmart)

No humidification

Placebo Comparator group

Description:

Subjects use dry CPAP / APAP

Treatment:

Device: No Humidification