Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-20 @ 10:57 PM
Study NCT ID:
NCT02779894
Status:
COMPLETED
Last Update Posted:
2018-02-26
First Post:
2016-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Apnoea Management by a Communication Based Technology (ICT)
Sponsor:
Hospital Clinic of Barcelona
Organization:
Study Overview
Official Title:
Applicability, Efficacy and Cost Effectiveness of Sleep Apnoea Hypopnea Syndrome (SAHS) Management by an Information and Communication Based Technology (ICT)
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: