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)
1 other identifier
interventional
151
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 11, 2016
CompletedFirst Posted
Study publicly available on registry
May 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 26, 2018
February 1, 2018
1.7 years
April 11, 2016
February 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evaluation of the two SAHS management programs
Quebec sleep questionnaire
3 months
Evaluation of the two SAHS management programs
Compliance to CPAP treatment. (Number of hours that the patient uses CPAP)
3 months
Secondary Outcomes (1)
Cost-effectiveness of the two SAHS management programs
3 months
Study Arms (2)
Hospital group
NO INTERVENTIONPatients 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
OTHERPatients 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Clinical suspicion of SAHS
- Use of Smartphone and internet
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clinic
Barcelona, 08036, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Josep M Montserrat
Hospital Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
April 11, 2016
First Posted
May 23, 2016
Study Start
November 1, 2015
Primary Completion
July 1, 2017
Study Completion
December 1, 2017
Last Updated
February 26, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will share