Telemonitoring for the Recuperation of Patients With CPAP

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.

Study Overview

• Status: Recruiting
• Conditions: Apnea, Obstructive
• Intervention / Treatment: Other: In Hospital; Other: Telemedicine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josep M Montserrat, Prof; Phone Number: 932275746; Email: jmmontserrat@ub.edu

Study Locations

• Spain
  • Cataluña
    • Barcelona, Cataluña, Spain, 08036
      • Recruiting
      • Josep M Montserrat Canal
      • Contact: Monique C Suarez Giron, MD PhD; Phone Number: 5746 932275746; Email: mcsuarez@clinic.cat
      • Contact: Onintza Garmendia, MsC; Phone Number: 5746 932275746; Email: garmendia@clinic.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Instituto de Salud Carlos III
• Investigators: Study Director: Josep M Montserrat, Prof, Hospital Clinic/Universitat de Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): May 20, 2021

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: PI17/01068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No