A Comparison of CPAP With and Without Humidification: A Pilot Study

Fisher & Paykel Healthcare

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Without ThermoSmart; Device: ThermoSmart

Study type: Interventional

Funder types: Industry

Identifiers

NCT02423681

CIA-101

Details and patient eligibility

About

To compare a group of patients with our standard treatment of continuous positive airway pressure (CPAP) and another group of patients with CPAP and a humidifier attached. The therapy cost and the successfulness of the treatment will be measured. A humidifier is a water chamber that is currently added to CPAP only if the patients needs it.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Older than 18 years of age
• Diagnosed with OSA (obstructive sleep apnea) and eligible for CPAP treatment under local requirements (NICE guidelines: AHI (apnea hypopnea index) ≥ 15, or AHI > 5 with significant daytime sleepiness)
• Naïve to CPAP therapy, i.e. have not been prescribed, or used CPAP in the last 5 years.
• Fluent in spoken and written English

Exclusion criteria

• Significant uncontrolled cardiac disease, as per the principal investigator's discretion
• Co-existing lung disease, as per the principal investigator's discretion
• Co-existing sleep disorder, such a predominant central sleep apnoea
• Pregnancy
• Participants that are unable or unwilling to give informed consent.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups, including a placebo group

Heated humidification as first intention (HH1st)

Active Comparator group

Description:

Subjects receive heated humidification as first intention with ThermoSmart

Treatment:

Device: ThermoSmart

Non-heated humidification

Placebo Comparator group

Description:

Subjects will receive no humidification. However they can be switched to the humidification group if patients complains of nasal dryness, congestion, nose bleed or if they had significant leak that cannot be resolved by two changes of mask.

Treatment:

Device: Without ThermoSmart