Telemedicine for CPAP Therapy Control in OSA

Study Overview
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Brief Summary
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Obstructive sleep apnea is a very frequent syndrome and Continuous Positive Airway Pressure (CPAP) is the gold standard treatment. Nevertheless, obtaining the sufficient compliance is complex. New communication technologies and the current health challenges, such as aging and high health care costs have encouraged the interest in new strategies. As showed recently, telemedicine is an alternative (Isetta, Thorax 2015) in patients that use internet and mobile technologies usually. However, there is a significant percentage of patients that does not use Internet and mobile technologies, only the 58% of patients over 65 years uses them (Dorsey, NEJM 2016). Although evidence regarding telemedicine is conflicting, it suggest that it's applicability depends in patient's characteristics and it is necessary to personalize it to make it safe and effective (Takahashi, Arch Intern Med 2012). That's why the investigators believe that the next step should be to choose those patient's that doesn't use Internet or mobile technologies and to verify the applicability of a telematic system that could facilitate the extra hospital management of this patient's. The aim of the study is to evaluate the telematic management of various outcomes that are emitted by CPAP machine, and by an app where the patient's will answer different questions regarding their treatment during the three months of study period.

Detailed Description
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We include OSA patient's that are not familiarized with the use of internet and mobile technologies and with CPAP prescription. They follow up an adaptation session where an automatic CPAP machine is delivered. Patient's are titrated with this automatic device in 5-7 days and are treated with the automatic device during 3 months. The other part of the follow up consists on a voicemail where the patient can contact the sleep unit 24h a day and on a tablet, with an special app where the patient's answer a questionnaire once two weeks.

Official Title
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Telemedicine for CPAP Therapy Control in OSA Patients With Limited Internet Knowledge

Conditions
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OSA

Intervention / Treatment
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* Other: Telematic follow up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OSA diagnosis and CPAP prescription No use of internet or mobile devices Exclusion Criteria: Unstable diseases and severe comorbidities Previous CPAP treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>These OSA patient's are not familiarized with the use of internet and mobile technologies and with CPAP prescription. They follow the intervetion follow up that consists in an adaptation session where the tecnitian delivers them an automatic CPAP machine. Patient's are titrated with this automatic device in 5-7 days and are treated with the automatic device during 3 months. The other part of the follow up consists on a voicemail where the patient can contact us 24h a day and on an , with an internet-connected tablet with a special app where the patient's answer a questionnaire once two weeks. | Other: Telematic follow up<br>* Follow-up of OSA patients through automatic CPAP with data transmission (Dreamstation; Philips Respironics), a 24-hour voice mailbox available for questions or problems, and an Internet-connected (4G) tablet with a friendly mobile application for simple questionnaires.<br>|
| No Intervention: Control group<br>These patient's are patient's that follow the process that all patient's take during CPAP treatment. During the three months of study, the follow up will be the usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the telematic CPAP follow up | CPAP adherence: Hours of use | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of titration and follow up of data transmitted by CPAP | Leaks, Residual events | 3 months | 
| Evaluate the effects of treatment in patient's symptomatology | Epworth questionnaire | 3 months | 
| Evaluate the satisfaction of patient's and professionals | Satisfaction questionnaire | 3 months | 
| Evaluate the effect of CPAP treatment and telematic follow up | EQ5D questionnaire | 3 months | 
| To compare the cost of the telematic follow up group vs hospital group | Bayesian cost analysis | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA, CPAP management, Telemedicine