Sleep Apnoea Management by a Communication Based Technology (ICT)

Hospital Clinic of Barcelona

Status: Completed

Conditions: Telemedicine; Obstructive Sleep Apnea

Treatments: Other: Remote control of patients

Study type: Interventional

Funder types: Other

Identifiers

NCT02779894

PI14/00416

Details and patient eligibility

About

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

Full 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.

Enrollment: 151 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

151 participants in 2 patient groups

Hospital group

No Intervention group

Description:

Patients referred to the sleep unit and randomized to Hospital group. Participants will be diagnosed in the hospital either by Polysomnography , Respiratory Polygraphy or one night Home Respiratory Polygraphy. In case of requiring CPAP treatment, the titration and adjustment of patient's will be accomplished at the hospital. This patient's will be monitored during 3 months of the study at the hospital.

ICT group

Other group

Description:

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.

Treatment:

Other: Remote control of patients