Apnea, Obstructive
Conditions
Brief summary
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.
Detailed description
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: * In-hospital classic management: Patients are followed regularly in the hospital with a face-to-face visit by the Sleep unit nurse. * Telemedicine management: telemedicine support with mobile app, voicemail and CPAP remote monitoring.
Interventions
OTHERTelemedicine
Remote CPAP monitoring, mobile app and voice mail
OTHERIn Hospital
Face-to-face follow up
Sponsors
Instituto de Salud Carlos III
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
4-weeks randomized with parallel groups study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years, * CPAP treatment initiated ≥1 month and \<12 months * CPAP compliance below 5.5 hours per night, * Regular use of Smartphone and mobile apps.
Exclusion criteria
* Clinical suspicion or other confirmed sleep pathology, * Severe nasal obstruction that prevents the use of CPAP, * Physical-psychological inability to follow questionnaires and the program, * Patients undergoing uvulopalatopharyngoplasty, * Cheyne-Stokes syndrome, * Pregnancy, * Rejection in the initial test with CPAP during the training and education session and * Failure to obtain informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPAP use | 4-weeks | Compliance to CPAP treatment (Number of hours that the patient uses CPAP) will be taken as the main variable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessment | 4-weeks | Functional Outcomes Sleep Questionnaire (FOSQ) and EuroQol-5D (EQ-5D) |
| Sleepiness assessment | 4 weeks | Epworth sleepiness scale (ESS) |
| Satisfaction assessment | 4 weeks | Satisfaction questionnaire |
Countries
Spain
Contacts
Primary ContactJosep M Montserrat, Prof
Outcome results
None listed