Telemonitoring for the Recuperation of Patients With CPAP

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Telemonitoring for the Recuperation of Patients With CPAP

Conditions
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Apnea, Obstructive

Intervention / Treatment
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* Other: Telemedicine
* Other: In Hospital


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4-weeks randomized with parallel groups study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hospital management<br>Patient's receive no intervention, the follow up is the usual for a patient following CPAP therapy. | Other: In Hospital<br>* Face-to-face follow up<br>|
| Experimental: Telemedicine management<br>CPAP remote monitoring of patients, including a mobile application and a voicemail. | Other: Telemedicine<br>* Remote CPAP monitoring, mobile app and voice mail<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 4 weeks | 
| Satisfaction assessment | Satisfaction questionnaire | 4 weeks |