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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-10-31

Brief Summary

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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.

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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

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Heated humidification as first intention (HH1st)

Subjects receive heated humidification as first intention with ThermoSmart

Group Type ACTIVE_COMPARATOR

ThermoSmart

Intervention Type DEVICE

Heated humidification as first intention (HH1st) with ThermoSmart

Non-heated humidification

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.

Group Type PLACEBO_COMPARATOR

Without ThermoSmart

Intervention Type DEVICE

ThermoSmart is switched off

Interventions

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ThermoSmart

Heated humidification as first intention (HH1st) with ThermoSmart

Intervention Type DEVICE

Without ThermoSmart

ThermoSmart is switched off

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No