Obstructive Sleep Apnea Clinical Trial
Official title:
Evaluation of Overall Therapy Cost Comparing First Intention and Second Intention Heated Humidification for CPAP: A Pilot Study.
Verified date | February 2017 |
Source | Fisher and Paykel Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Lung Function and Sleep Unit, St George's Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Fisher and Paykel Healthcare |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall cost of equipment | (cost of equipment required for CPAP therapy, including CPAP device and mask, and all related consumables | 6 months | |
Primary | Number and type of additional interventions | The number and type of additional interventions (masks, nasal steroids) and the associated cost | 6 months | |
Primary | Duration of appointments | Time spent with/on each patient (i.e preparation and follow-up time as well as appointment time) | 6 months | |
Primary | Number of unplanned follow-ups | number of unplanned follow-ups | 6 months | |
Secondary | Adherence to therapy | Compliance data from the device | 6 months | |
Secondary | Therapy Acceptance | Number of withdrawals and drop out from the therapy | 6 months | |
Secondary | Apnea Hypopnea Index (AHI) | AHI to measure the treatment efficacy | 6 months | |
Secondary | Leak | Total system leak from the device | 6 months | |
Secondary | Side effects and symptoms reported | Any side effects and symptoms reported with the therapy | 6 months | |
Secondary | Self-reported satisfaction | Self-reported satisfaction via treatment questionnaires | 6 months | |
Secondary | Patient sleeping environment temperature and humidity | The temperature and humidity of the patient's environment as measured by a humidity logger | 6 months |
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