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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heated humidification as first intention (HH1st) | Active Comparator | Subjects receive heated humidification as first intention with ThermoSmart |
|
| Non-heated humidification | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ThermoSmart | Device | Heated humidification as first intention (HH1st) with ThermoSmart |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Parsons, Chief Clinical Physiologist | Lung Function and Sleep Unit, St George's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lung Function and Sleep Unit, St George's Hospital | London | United Kingdom |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Without ThermoSmart | Device | ThermoSmart is switched off |
|
| 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 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |