Sleep Apnoea Management by a Communication Based Technology (ICT)

NCT ID: NCT02779894

Last Updated: 2018-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-12-31

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.

Conditions

Obstructive Sleep Apnea; Telemedicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Hospital group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

ICT group

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.

Group Type: OTHER

Remote control of patients

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

Communication based technology

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Jose M. Montserrat

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josep M Montserrat

Role: STUDY_DIRECTOR

Hospital Clinic

Locations

Hospital Clinic

Barcelona, , Spain

Countries

Spain

Other Identifiers

PI14/00416

Identifier Type: -

Identifier Source: org_study_id