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

NCT ID: NCT03792880

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2021-12-28

Brief 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.

Detailed Description

Low CPAP compliance in OSAHS could mean that its possible cardiovascular benefits are not achieved. Telemedicine can be an effective tool to increase CPAP compliance with low cost.

The researchers propose to carry out a randomized study about patients with severe OSAHS and few symptoms, who are expected to have low CPAP compliance.

The main objective is to evaluate if a telematic control and self-management program can increase the compliance with CPAP treatment compared to conventional follow-up, getting at least 90% of patients to use CPAP ≥ 4 hours per day.

Sixty patients from the Pneumology departments of two hospitals, diagnosed with severe OSAHS and with few symptoms (Epworth Sleepiness Scale ≤10) will be randomized to two follow-up groups, telematic and conventional, for 6 months. Patients in the intervention group (telematic monitoring) will collect variables related to symptoms of sleep apnea and side effects of CPAP treatment, using their own smartphone or a tablet provided during the study if they prefer. Other variables as the hours per day of CPAP use, leaks and residual apnea-hypopnea index (AHI) will be transmitted daily and automatically from latest generation CPAP. All information will be processed and each variable will generate alarms and instructions for each patient, allowing the self-management and an early solution of the possible problems related to the treatment. Alarms may also be generated in the database if the professional intervention is necessary.

In addition, before starting CPAP treatment and after six months of treatment, patients will be monitored during a week with a watch-like device. Variables related to circadian rhythm will be collected and analyzed to know the effect of CPAP treatment in both groups (control and intervention groups).

Conditions

Obstructive Sleep Apnea; Telemedicine; Compliance, Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control arm

Usual follow-up in Healthcare System for patients with obstructive sleep apnea and CPAP treatment

Group Type: ACTIVE_COMPARATOR

Habitual follow-up in Healthcare System

Intervention Type: BEHAVIORAL

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.

Intervention arm

Usual follow-up in the Healthcare System for patients with obstructive sleep apnea and CPAP treatment and a telematic control and self-management program

Group Type: EXPERIMENTAL

Telematic control and self-management program

Intervention Type: BEHAVIORAL

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.

Habitual follow-up in Healthcare System

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients with a recent diagnostic of OSAHS with AHI≥ 30 and indication of CPAP.
• Age≥ 18 years
• Few symptoms, so that, without hypersomnolence (Epworth sleepiness scale ≤ 10)
• Absence of clinic suspect or confirmation of other sleep pathology
• With interest in the use of new technologies

Exclusion Criteria

• Nasal obstruction that prevents the use of CPAP
• Psycho-physical inability to complete questionnaires and carry out the program
• Patients undergoing uvulopalatopharyngoplasty
• Cheyne-Stoke syndrome
• Pregnancy
• Absence of informed consent
• Shift work in the last 3 months and transmeridian trips in the last month.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virgen del Puerto Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

María Ángeles Sánchez Quiroga

Role: PRINCIPAL_INVESTIGATOR

Virgen del Puerto Hospital

Locations

Virgen del Puerto Hospital

Plasencia, Cáceres, Spain

San Pedro de Alcántara

Cáceres, , Spain

Countries

Spain

Other Identifiers

4/2016

Identifier Type: -

Identifier Source: org_study_id