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

Study Overview
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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.

Official Title
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Evaluation of Overall Therapy Cost Comparing First Intention and Second Intention Heated Humidification for CPAP: A Pilot Study.

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: ThermoSmart
* Device: Without ThermoSmart


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Heated humidification as first intention (HH1st)<br>Subjects receive heated humidification as first intention with ThermoSmart | Device: ThermoSmart<br>* Heated humidification as first intention (HH1st) with ThermoSmart<br>|
| Placebo Comparator: Non-heated humidification<br>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. | Device: Without ThermoSmart<br>* ThermoSmart is switched off<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall cost of equipment | (cost of equipment required for CPAP therapy, including CPAP device and mask, and all related consumables | 6 months | 
| Number and type of additional interventions | The number and type of additional interventions (masks, nasal steroids) and the associated cost | 6 months | 
| Duration of appointments | Time spent with/on each patient (i.e preparation and follow-up time as well as appointment time) | 6 months | 
| Number of unplanned follow-ups | number of unplanned follow-ups | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to therapy | Compliance data from the device | 6 months | 
| Therapy Acceptance | Number of withdrawals and drop out from the therapy | 6 months | 
| Apnea Hypopnea Index (AHI) | AHI to measure the treatment efficacy | 6 months | 
| Leak | Total system leak from the device | 6 months | 
| Side effects and symptoms reported | Any side effects and symptoms reported with the therapy | 6 months | 
| Self-reported satisfaction | Self-reported satisfaction via treatment questionnaires | 6 months | 
| Patient sleeping environment temperature and humidity | The temperature and humidity of the patient's environment as measured by a humidity logger | 6 months |