Sleep Apnoea Management by a Communication Based Technology (ICT)

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Telemedicine
• Interventions: Other: Remote control of patients

• Registration Number: NCT02779894
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

This project develops a new form of management of subjects with suspected SAHS and different sleep disorders by applying Information and communications technologies (ICT).

Detailed Description

Sleep apnea hypopnea syndrome (SAHS) is a prevalent disease with significant morbidity resulting in long waiting lists and high health care costs. Therefore, alternative cost-effective approaches are urgently needed. A possible procedure is telemedicine based on ICT.

The design of the study is prospective, randomized, controlled, open and parallel.

A ICT-based out of hospital management of SAHS is implemented to be compared with the classical in-hospital management.

The main objectives were the evaluation of both groups and the analysis of efficacy and cost effectiveness of two SAHS management programs.

This is a 3 month randomized, with parallel groups study. Participants will be patients with suspicion of SAHS derived to the Investigators' Sleep Unit.

Patients are randomized in two groups; 1) classical in-hospital group: polysomnography or home respiratory polygraphy (HRP), CPAP titration and treatment and hospital follow-up; and 2) ICT group: 3 consecutive HRPs, automatic CPAP treatment and control by phone/video conferences and data transmission by using a custom designed platform.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-23
• Primary Completion: 2017-07
• Study Completion: 2017-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• Clinical suspicion of SAHS
• Use of Smartphone and internet

Exclusion Criteria

• Severe hypersomnia
• Central apneas or other sleep disorder
• Previous CPAP treatment
• Unstable diseases
• Profession of risk
• Not able to complete questionnaires
• No written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICT group	Remote control of patients	Patients referred to the sleep unit and randomized to intervention group. Participants will be diagnosed at home by 3 night Home Respiratory Polygraphy. In case of requiring CPAP treatment, the adjustment will be performed at the CPAP supplier center, titration will be performed at home and patient's compliance and treatment will be controlled via remote. During the 3 months of the study patient's will be controlled via phono/video conferences and with a platform designed for the study.

Primary Outcome Measures

Name	Time	Method
Evaluation of the two SAHS management programs	3 months	Compliance to CPAP treatment. (Number of hours that the patient uses CPAP)

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness of the two SAHS management programs	3 months	Costs of visits and transport of both groups (Bayesian analysis techniques)

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Spain