Sleep Apnoea Management by a Communication Based Technology (ICT)

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Telemedicine

• 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

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