Sleep Apnoea Management by a Communication Based Technology (ICT)

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779894
• Other study ID #: PI14/00416
• Status: Completed
• Phase: N/A
• First received: April 11, 2016
• Last updated: February 22, 2018
• Start date: November 2015
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Telemedicine

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the two SAHS management programs	Quebec sleep questionnaire	3 months
Primary	Evaluation of the two SAHS management programs	Compliance to CPAP treatment. (Number of hours that the patient uses CPAP)	3 months
Secondary	Cost-effectiveness of the two SAHS management programs	Costs of visits and transport of both groups (Bayesian analysis techniques)	3 months