NCT04297163

Telemonitoring for the Recuperation of Patients With CPAP

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Apnea, Obstructive

Interventions

Type	Name	Description
OTHER	Telemedicine	Remote CPAP monitoring, mobile app and voice mail
OTHER	In Hospital	Face-to-face follow up

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-04-01
• Completion: 2021-05-20
• First posted: 2020-03-05
• Last updated: 2021-03-19

Locations

1 site across 1 country: Spain