Telemonitoring for the Recuperation of Patients With CPAP

Apnea, Obstructive Clinical Trial

Official title:

Telemonitoring for the Recuperation of Patients With CPAP

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04297163
• Other study ID #: PI17/01068
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: May 20, 2021

Study information

• Verified date: March 2021
• Source: Hospital Clinic of Barcelona
• Contact: Josep M Montserrat, Prof
• Phone: 932275746
• Email: jmmontserrat[@]ub.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: May 20, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea, Obstructive
• Sleep Apnea, Obstructive

Intervention

Other:
• Telemedicine
Remote CPAP monitoring, mobile app and voice mail
• In Hospital
Face-to-face follow up

Locations

Country	Name	City	State
Spain	Josep M Montserrat Canal	Barcelona	Cataluña

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPAP use	Compliance to CPAP treatment (Number of hours that the patient uses CPAP) will be taken as the main variable.	4-weeks
Secondary	Quality of life assessment	Functional Outcomes Sleep Questionnaire (FOSQ) and EuroQol-5D (EQ-5D)	4-weeks
Secondary	Sleepiness assessment	Epworth sleepiness scale (ESS)	4 weeks
Secondary	Satisfaction assessment	Satisfaction questionnaire	4 weeks