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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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This study is aimed at patients who do not achieve a minimum (≥4 hours/night) or optimal (≥5,5 hours/night) use of Continuous Positive Airway Pressure (CPAP) treatment and it is proposed to improve their adherence making a 4-weeks intervention using telemedicine tools: CPAP remote monitoring, a mobile application (app) and a voicemail. The concept of this work is to "recover" patients to minimum or optimal CPAP use.
Given the prevalence of Obstructive Sleep Apnea (OSA), the symptoms it produces, which is a risk factor for various entities and that, in addition, its treatment clearly improves others; its control must be optimized in an effective and cost-effective manner. The use of information and communication technologies (ICT) in this context can be very beneficial.
The design of the study is prospective, randomized, controlled, open and parallel.
A ICT-based out of hospital management of OSA is implemented to be compared with the classical in-hospital management.
The main objectives were to evaluate the effectiveness of of two OSA management programs: the in-hospital classic management versus a telemedicine program based on the use of ICTs in the recovery of patients with OSA who who do not meet the minimum treatment (4 hours) or in those who do not comply with the optimal use (5.5 hours).
This is a 4-weeks management randomized, with parallel groups study. Participants will be patients from the Sleep Unit of Hospital Clinic Barcelona with OSA diagnosis and CPAP treatment indication, who after a follow-up between 3-months and up to 5 years have a CPAP compliance below 5,5 hours/night.
Two management programs will be compared:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospital management | Active Comparator | Patient's receive no intervention, the follow up is the usual for a patient following CPAP therapy. |
|
| Telemedicine management | Experimental | CPAP remote monitoring of patients, including a mobile application and a voicemail. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine | Other | Remote CPAP monitoring, mobile app and voice mail |
| |
| Measure | Description | Time Frame |
|---|---|---|
| CPAP use | Compliance to CPAP treatment (Number of hours that the patient uses CPAP) will be taken as the main variable. | 4-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life assessment | Functional Outcomes Sleep Questionnaire (FOSQ) and EuroQol-5D (EQ-5D) | 4-weeks |
| Sleepiness assessment | Epworth sleepiness scale (ESS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josep M Montserrat, Prof | Contact | 932275746 | jmmontserrat@ub.edu |
| Name | Affiliation | Role |
|---|---|---|
| Josep M Montserrat, Prof | Hospital Clinic/Universitat de Barcelona | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Josep M Montserrat Canal | Recruiting | Barcelona | Catalonia | 08036 | Spain |
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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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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D006761 | Hospitals |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D006268 | Health Facilities |
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4-weeks randomized with parallel groups study.
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| In Hospital |
| Other |
Face-to-face follow up |
|
| 4 weeks |
| Satisfaction assessment | Satisfaction questionnaire | 4 weeks |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D005159 | Health Care Facilities Workforce and Services |