Clinical trial NCT04297163: Telemonitoring for the Recuperation of Patients With CPAP
Official title: Telemonitoring for the Recuperation of Patients With CPAP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Apnea, Obstructive
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2020-03-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4-weeks randomized with parallel groups study.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: CPAP use
timeFrame: 4-weeks
Secondary outcomes:
measure: Quality of life assessment
timeFrame: 4-weeks
measure: Sleepiness assessment
timeFrame: 4 weeks
measure: Satisfaction assessment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Josep M Montserrat Canal
state: Cataluña
Study officials:
affiliation: Hospital Clinic/Universitat de Barcelona
name: Josep M Montserrat, Prof
role: STUDY_DIRECTOR
References: