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Sleep Apnoea Management by a Communication Based Technology (ICT)

Primary Purpose

Obstructive Sleep Apnea, Telemedicine

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Remote control of patients
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea focused on measuring Sleep Apnea, Communication Based Technology, ICT

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Hospital group

ICT group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Evaluation of the two SAHS management programs
Quebec sleep questionnaire
Evaluation of the two SAHS management programs
Compliance to CPAP treatment. (Number of hours that the patient uses CPAP)

Secondary Outcome Measures

Cost-effectiveness of the two SAHS management programs
Costs of visits and transport of both groups (Bayesian analysis techniques)

Full Information

First Posted
April 11, 2016
Last Updated
February 22, 2018
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT02779894
Brief Title
Sleep Apnoea Management by a Communication Based Technology (ICT)
Official Title
Applicability, Efficacy and Cost Effectiveness of Sleep Apnoea Hypopnea Syndrome (SAHS) Management by an Information and Communication Based Technology (ICT)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Telemedicine
Keywords
Sleep Apnea, Communication Based Technology, ICT

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hospital group
Arm Type
No Intervention
Arm 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.
Arm Title
ICT group
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Remote control of patients
Other Intervention Name(s)
Communication based technology
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluation of the two SAHS management programs
Description
Quebec sleep questionnaire
Time Frame
3 months
Title
Evaluation of the two SAHS management programs
Description
Compliance to CPAP treatment. (Number of hours that the patient uses CPAP)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Cost-effectiveness of the two SAHS management programs
Description
Costs of visits and transport of both groups (Bayesian analysis techniques)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep M Montserrat
Organizational Affiliation
Hospital Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Sleep Apnoea Management by a Communication Based Technology (ICT)

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