Obstructive Sleep Apnea
Conditions
Brief summary
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.
Interventions
DEVICEThermoSmart
Heated humidification as first intention (HH1st) with ThermoSmart
DEVICEWithout ThermoSmart
ThermoSmart is switched off
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of appointments | 6 months | Time spent with/on each patient (i.e preparation and follow-up time as well as appointment time) |
| Number of unplanned follow-ups | 6 months | number of unplanned follow-ups |
| Overall cost of equipment | 6 months | (cost of equipment required for CPAP therapy, including CPAP device and mask, and all related consumables |
| Number and type of additional interventions | 6 months | The number and type of additional interventions (masks, nasal steroids) and the associated cost |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects and symptoms reported | 6 months | Any side effects and symptoms reported with the therapy |
| Adherence to therapy | 6 months | Compliance data from the device |
| Patient sleeping environment temperature and humidity | 6 months | The temperature and humidity of the patient's environment as measured by a humidity logger |
| Self-reported satisfaction | 6 months | Self-reported satisfaction via treatment questionnaires |
| Therapy Acceptance | 6 months | Number of withdrawals and drop out from the therapy |
| Apnea Hypopnea Index (AHI) | 6 months | AHI to measure the treatment efficacy |
| Leak | 6 months | Total system leak from the device |
Countries
United Kingdom
Outcome results
None listed