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

Virgen del Puerto Hospital

Status: Completed

Conditions: Compliance, Patient; Telemedicine; Obstructive Sleep Apnea

Treatments: Behavioral: Habitual follow-up in Healthcare System; Behavioral: Telematic control and self-management program

Study type: Interventional

Funder types: Other

Identifiers

NCT03792880

4/2016

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control arm

Active Comparator group

Description:

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

Treatment:

Behavioral: Habitual follow-up in Healthcare System

Intervention arm

Experimental group

Description:

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

Treatment:

Behavioral: Habitual follow-up in Healthcare System

Behavioral: Telematic control and self-management program