Telemonitoring for the Recuperation of Patients With CPAP
Primary Purpose
Apnea, Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Telemedicine
In Hospital
Sponsored by
About this trial
This is an interventional supportive care trial for Apnea, Obstructive
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years,
- CPAP treatment initiated ≥1 month and <12 months
- CPAP compliance below 5.5 hours per night,
- Regular use of Smartphone and mobile apps.
Exclusion Criteria:
- Clinical suspicion or other confirmed sleep pathology,
- Severe nasal obstruction that prevents the use of CPAP,
- Physical-psychological inability to follow questionnaires and the program,
- Patients undergoing uvulopalatopharyngoplasty,
- Cheyne-Stokes syndrome,
- Pregnancy,
- Rejection in the initial test with CPAP during the training and education session and
- Failure to obtain informed consent.
Sites / Locations
- Josep M Montserrat CanalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Hospital management
Telemedicine management
Arm Description
Patient's receive no intervention, the follow up is the usual for a patient following CPAP therapy.
CPAP remote monitoring of patients, including a mobile application and a voicemail.
Outcomes
Primary Outcome Measures
CPAP use
Compliance to CPAP treatment (Number of hours that the patient uses CPAP) will be taken as the main variable.
Secondary Outcome Measures
Quality of life assessment
Functional Outcomes Sleep Questionnaire (FOSQ) and EuroQol-5D (EQ-5D)
Sleepiness assessment
Epworth sleepiness scale (ESS)
Satisfaction assessment
Satisfaction questionnaire
Full Information
NCT ID
NCT04297163
First Posted
February 27, 2020
Last Updated
March 18, 2021
Sponsor
Hospital Clinic of Barcelona
Collaborators
Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT04297163
Brief Title
Telemonitoring for the Recuperation of Patients With CPAP
Official Title
Telemonitoring for the Recuperation of Patients With CPAP
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
May 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Instituto de Salud Carlos III
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is aimed at patients who do not achieve a minimum (≥4 hours/night) or optimal (≥5,5 hours/night) use of Continuous Positive Airway Pressure (CPAP) treatment and it is proposed to improve their adherence making a 4-weeks intervention using telemedicine tools: CPAP remote monitoring, a mobile application (app) and a voicemail. The concept of this work is to "recover" patients to minimum or optimal CPAP use.
Detailed Description
Given the prevalence of Obstructive Sleep Apnea (OSA), the symptoms it produces, which is a risk factor for various entities and that, in addition, its treatment clearly improves others; its control must be optimized in an effective and cost-effective manner. The use of information and communication technologies (ICT) in this context can be very beneficial.
The design of the study is prospective, randomized, controlled, open and parallel.
A ICT-based out of hospital management of OSA is implemented to be compared with the classical in-hospital management.
The main objectives were to evaluate the effectiveness of of two OSA management programs: the in-hospital classic management versus a telemedicine program based on the use of ICTs in the recovery of patients with OSA who who do not meet the minimum treatment (4 hours) or in those who do not comply with the optimal use (5.5 hours).
This is a 4-weeks management randomized, with parallel groups study. Participants will be patients from the Sleep Unit of Hospital Clinic Barcelona with OSA diagnosis and CPAP treatment indication, who after a follow-up between 3-months and up to 5 years have a CPAP compliance below 5,5 hours/night.
Two management programs will be compared:
In-hospital classic management: Patients are followed regularly in the hospital with a face-to-face visit by the Sleep unit nurse.
Telemedicine management: telemedicine support with mobile app, voicemail and CPAP remote monitoring.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea, Obstructive
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
4-weeks randomized with parallel groups study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hospital management
Arm Type
Active Comparator
Arm Description
Patient's receive no intervention, the follow up is the usual for a patient following CPAP therapy.
Arm Title
Telemedicine management
Arm Type
Experimental
Arm Description
CPAP remote monitoring of patients, including a mobile application and a voicemail.
Intervention Type
Other
Intervention Name(s)
Telemedicine
Intervention Description
Remote CPAP monitoring, mobile app and voice mail
Intervention Type
Other
Intervention Name(s)
In Hospital
Intervention Description
Face-to-face follow up
Primary Outcome Measure Information:
Title
CPAP use
Description
Compliance to CPAP treatment (Number of hours that the patient uses CPAP) will be taken as the main variable.
Time Frame
4-weeks
Secondary Outcome Measure Information:
Title
Quality of life assessment
Description
Functional Outcomes Sleep Questionnaire (FOSQ) and EuroQol-5D (EQ-5D)
Time Frame
4-weeks
Title
Sleepiness assessment
Description
Epworth sleepiness scale (ESS)
Time Frame
4 weeks
Title
Satisfaction assessment
Description
Satisfaction questionnaire
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years,
CPAP treatment initiated ≥1 month and <12 months
CPAP compliance below 5.5 hours per night,
Regular use of Smartphone and mobile apps.
Exclusion Criteria:
Clinical suspicion or other confirmed sleep pathology,
Severe nasal obstruction that prevents the use of CPAP,
Physical-psychological inability to follow questionnaires and the program,
Patients undergoing uvulopalatopharyngoplasty,
Cheyne-Stokes syndrome,
Pregnancy,
Rejection in the initial test with CPAP during the training and education session and
Failure to obtain informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josep M Montserrat, Prof
Phone
932275746
Email
jmmontserrat@ub.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep M Montserrat, Prof
Organizational Affiliation
Hospital Clinic/Universitat de Barcelona
Official's Role
Study Director
Facility Information:
Facility Name
Josep M Montserrat Canal
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monique C Suarez Giron, MD PhD
Phone
932275746
Ext
5746
Email
mcsuarez@clinic.cat
First Name & Middle Initial & Last Name & Degree
Onintza Garmendia, MsC
Phone
932275746
Ext
5746
Email
garmendia@clinic.cat
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Telemonitoring for the Recuperation of Patients With CPAP
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