NCT02779894

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea
• Telemedicine

Interventions

Type	Name	Description
OTHER	Remote 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

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-07-01
• Completion: 2017-12-01
• First posted: 2016-05-23
• Last updated: 2018-02-26

Locations

1 site across 1 country: Spain