Telemonitoring for the Recuperation of Patients With CPAP

NCT04297163 | Unknown

• 1 other identifier: PI17/01068
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• CPAP use

  Compliance to CPAP treatment (Number of hours that the patient uses CPAP) will be taken as the main variable.

  4-weeks

Secondary Outcomes (3)

• Quality of life assessment

  4-weeks

• Sleepiness assessment

  4 weeks

• Satisfaction assessment

  4 weeks

Study Arms (2)

Hospital management

ACTIVE COMPARATOR

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

Other: In Hospital

Telemedicine management

EXPERIMENTAL

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

Other: Telemedicine

Interventions

Telemedicine OTHER

Remote CPAP monitoring, mobile app and voice mail

Telemedicine management

In Hospital OTHER

Face-to-face follow up

Hospital management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Josep M Montserrat Canal

Barcelona, Catalonia, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Telemedicine; Hospitals

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Josep M Montserrat, Prof

  Hospital Clinic/Universitat de Barcelona

  STUDY DIRECTOR

Central Study Contacts

Josep M Montserrat, Prof

CONTACT

932275746; jmmontserrat@ub.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pneumologist consultor senior

Model Details: 4-weeks randomized with parallel groups study.

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 5, 2020
• Study Start: November 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: May 20, 2021
• Last Updated: March 19, 2021

Record last verified: 2021-03

Locations

ES (1)