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Global Self-management Telematic Support for Patients With Obstructive Sleep Apnea.

NCT03792880 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-04-26

No results posted yet for this study

Summary

This clinical trial compares the usual follow-up to a program of telematic control and self-management in a group of patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS), few symptoms and treated with continuous positive airway pressure (CPAP). The objective of the intervention is to achieve a CPAP compliance of ≥4 hours per day in at least 90% of the subjects.

Conditions

Interventions

BEHAVIORAL

Telematic control and self-management program

During 6 months with CPAP treatment, patients must complete some questionnaires about the presence of refreshing sleep and side effects with the frequency established, using a computing application. Patients can download this application on their own smartphone but, if they prefer, they can be provided with a tablet during the study with this application installed. A set of variables will be collected using an automatic and wireless transmission from latest generation CPAP to control the CPAP compliance and tolerance. All data will be processed in a platform to generate alarms, which will be controled daily by a researcher, as well as solutions to the problems presented during the monitoring.

BEHAVIORAL

Habitual follow-up in Healthcare System

According to the SEPAR regulation, patients treated with CPAP should be evaluated by the pulmonologist one month after beginning treatment, every 3 months during the first year, every 6 months during the second year and annually from the third year.

Sponsors & Collaborators

  • Virgen del Puerto Hospital

    lead OTHER

Principal Investigators

  • María Ángeles Sánchez Quiroga · Virgen del Puerto Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2020-12-28
Completion
2021-12-28

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03792880 on ClinicalTrials.gov