Sleep Apnoea Management by a Communication Based Technology (ICT)

Applicability, Efficacy and Cost Effectiveness of Sleep Apnoea Hypopnea Syndrome (SAHS) Management by an Information and Communication Based Technology (ICT)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02779894

Enrollment

151

Registered

2016-05-23

Start date

2015-11-30

Completion date

2017-12-31

Last updated

2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Telemedicine

Keywords

Sleep Apnea, Communication Based Technology, ICT

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.

Interventions

OTHERRemote control of patients

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of the two SAHS management programs	3 months	Quebec sleep questionnaire

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026