Sleep Apnoea Management by a Communication Based Technology (ICT)

Hospital Clinic of Barcelona151 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

151

Conditions

Obstructive Sleep Apnea Telemedicine

Interventions

Remote control of patientsOTHER

Diagnosis outside the hospital (3 Home PR) CPAP (if needed) titration at home REmote control of patient's during 3 months by video or phonoconference

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Clinic

Barcelona, Spain

Outcomes

Primary Outcomes

Evaluation of the two SAHS management programs

Quebec sleep questionnaire

Time frame: 3 months

Evaluation of the two SAHS management programs

Compliance to CPAP treatment. (Number of hours that the patient uses CPAP)

Time frame: 3 months

Secondary Outcomes

Cost-effectiveness of the two SAHS management programs

Costs of visits and transport of both groups (Bayesian analysis techniques)

Time frame: 3 months

Data from ClinicalTrials.gov

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