Telemonitoring for the Recuperation of Patients With CPAP

NCT ID: NCT04297163

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-05-20

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.

Conditions

Apnea, Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Hospital management

Patient's receive no intervention, the follow up is the usual for a patient following CPAP therapy.

Group Type: ACTIVE_COMPARATOR

In Hospital

Intervention Type: OTHER

Face-to-face follow up

Telemedicine management

CPAP remote monitoring of patients, including a mobile application and a voicemail.

Group Type: EXPERIMENTAL

Telemedicine

Intervention Type: OTHER

Remote CPAP monitoring, mobile app and voice mail

Interventions

Telemedicine

Remote CPAP monitoring, mobile app and voice mail

Intervention Type: OTHER

In Hospital

Face-to-face follow up

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Jose M. Montserrat

Pneumologist consultor senior

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josep M Montserrat, Prof

Role: STUDY_DIRECTOR

Hospital Clinic/Universitat de Barcelona

Locations

Josep M Montserrat Canal

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Josep M Montserrat, Prof

Role: CONTACT

jmmontserrat@ub.edu

932275746

Facility Contacts

Monique C Suarez Giron, MD PhD

Role: primary

mcsuarez@clinic.cat

932275746 ext. 5746

Onintza Garmendia, MsC

Role: backup

garmendia@clinic.cat

932275746 ext. 5746

Other Identifiers

PI17/01068

Identifier Type: -

Identifier Source: org_study_id