Follow-up of Apneic Patients by Visio-consultation (VISIOSAS)
Primary Purpose
Obstructive Sleep Apnea
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Videoconsultation
Sponsored by
About this trial
This is an interventional health services research trial for Obstructive Sleep Apnea focused on measuring Telemedicine, Medical follow-up
Eligibility Criteria
Inclusion Criteria:
- Apneic patient treated with CPAP for more than 12 months and having an annual scheduled follow-up visit.
- Adult patient who can give an informed consent.
- Patient with access to a media (Smartphone, tablet or computer) and an Internet connection at home.
Exclusion Criteria:
- Patient unable to use or understand the digital system.
- Patient under guardianship or deprived of liberty
- Pregnant woman
- Patient in a period of exclusion from another clinical trial
Sites / Locations
- CHU Grenoble-AlpesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Video consultation
Face-to-face consultation
Arm Description
Patients in this group will have a continuous positive pressure follow-up visit by videoconsultation
Patients in this group will have a continuous positive pressure follow-up visit by face-to-face consultation
Outcomes
Primary Outcome Measures
Therapeutic adherence to CPAP
Non inferiority of visioconsultation compared to face-to-face consultation in terms of therapeutic adherence to CPAP evaluated by the difference in compliance 3 months before and 3 months after the consultation
Consultation cost
Non inferiority of visioconsultation compared to face-to-face consultation in terms of consultation cost evaluated by the difference in cost between the 2 types of consultation
Patient satisfaction: questionnaire
Non inferiority of visioconsultation compared to face-to-face consultation in terms of patient satisfaction evaluated by the VSQ-VF questionnaire
Secondary Outcome Measures
Sleepiness related to CPAP
Epworth Sleepiness Scale
Tiredness related to CPAP
Pichot's fatigue scale
Evaluate the quality of CPAP treatment (Residual AHI)
Evaluate the quality of CPAP treatment by the residual Apnea-Hypopnea Index(AHI) (event/hour)
Evaluate the quality of CPAP treatment (adverse events)
Evaluate the quality of CPAP treatment by the adverse event reporting
Evaluate the quality of CPAP treatment (mask leaks level)
Evaluate the quality of CPAP treatment by the CPAP mask leaks level (litre/min)
Evaluate the quality of CPAP treatment (visits by the health care provider): number of visits by the health care provider and the reasons for these visits
Evaluate the quality of CPAP treatment by collecting the number of visits by the health care provider and the reasons for these visits
Assess the risk factors associated with OSA in patients treated with CPAP (weight)
Body weight (kg)
Assess the risk factors associated with OSA in patients treated with CPAP (level of physical activity)
Evaluation of the level of physical activity by actimetry
Assess the risk factors associated with OSA in patients treated with CPAP (blood pressure)
Blood pressure by blood pressure monitoring at home
Full Information
NCT ID
NCT04547543
First Posted
September 7, 2020
Last Updated
November 7, 2022
Sponsor
University Hospital, Grenoble
Collaborators
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT04547543
Brief Title
Follow-up of Apneic Patients by Visio-consultation
Acronym
VISIOSAS
Official Title
Visio-consultation Compared to Face-to-face Consultation During the Follow-up of Apneic Patients Treated by Continuous Positive Airway Pressure (CPAP)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective multicenter open-label randomized clinical trial comparing videoconsultation to a face-to-face consultation during the follow-up of apneic patients treated by continuous positive pressure (CPAP) .
Detailed Description
The annual management of Obstructive Sleep Apnea (OSA) patients treated by continuous positive air pressure (CPAP) aims to maintain an optimal level of care while offering to the patients a combined management of their pathology. This management aims to reduce the risk of cardio-metabolic pathologies.
However, the high prevalence of OSA in the general population reduces the ability to explore undiagnosed patients. The contribution of videoconsultation is now available and allows the management of OSA patients treated by CPAP.
The objective of this study is to compare the videoconsultation to a face-to-face consultation during the follow-up of apneic patients treated by continuous positive pressure (CPAP) .
The results of this study could provide very important new data on the impact of videoconsultation on the monitoring a chronic respiratory pathology such as sleep apnea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Telemedicine, Medical follow-up
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Video consultation
Arm Type
Other
Arm Description
Patients in this group will have a continuous positive pressure follow-up visit by videoconsultation
Arm Title
Face-to-face consultation
Arm Type
No Intervention
Arm Description
Patients in this group will have a continuous positive pressure follow-up visit by face-to-face consultation
Intervention Type
Other
Intervention Name(s)
Videoconsultation
Intervention Description
Patient randomized on video-consultation group will have a video-consultation with the investigator within 3 months after the randomization. During this consultation, the investigator performs a clinical interrogation in order to collect anthropometric parameters: (sex, age, weight, height, body mass index (BMI)), blood pressure (by blood pressure monitor at home), the level of physical activity (by Actimetry over 7 days), smoking status and alcohol status
Primary Outcome Measure Information:
Title
Therapeutic adherence to CPAP
Description
Non inferiority of visioconsultation compared to face-to-face consultation in terms of therapeutic adherence to CPAP evaluated by the difference in compliance 3 months before and 3 months after the consultation
Time Frame
3 months after consultation
Title
Consultation cost
Description
Non inferiority of visioconsultation compared to face-to-face consultation in terms of consultation cost evaluated by the difference in cost between the 2 types of consultation
Time Frame
3 months after consultation
Title
Patient satisfaction: questionnaire
Description
Non inferiority of visioconsultation compared to face-to-face consultation in terms of patient satisfaction evaluated by the VSQ-VF questionnaire
Time Frame
3 months after consultation
Secondary Outcome Measure Information:
Title
Sleepiness related to CPAP
Description
Epworth Sleepiness Scale
Time Frame
3 and 12 after consultation
Title
Tiredness related to CPAP
Description
Pichot's fatigue scale
Time Frame
3 and 12 months after consultation
Title
Evaluate the quality of CPAP treatment (Residual AHI)
Description
Evaluate the quality of CPAP treatment by the residual Apnea-Hypopnea Index(AHI) (event/hour)
Time Frame
3 and 12 months after consultation
Title
Evaluate the quality of CPAP treatment (adverse events)
Description
Evaluate the quality of CPAP treatment by the adverse event reporting
Time Frame
3 and 12 months after consultation
Title
Evaluate the quality of CPAP treatment (mask leaks level)
Description
Evaluate the quality of CPAP treatment by the CPAP mask leaks level (litre/min)
Time Frame
3 and 12 months after consultation
Title
Evaluate the quality of CPAP treatment (visits by the health care provider): number of visits by the health care provider and the reasons for these visits
Description
Evaluate the quality of CPAP treatment by collecting the number of visits by the health care provider and the reasons for these visits
Time Frame
3 and 12 months after consultation
Title
Assess the risk factors associated with OSA in patients treated with CPAP (weight)
Description
Body weight (kg)
Time Frame
12 months after consultation
Title
Assess the risk factors associated with OSA in patients treated with CPAP (level of physical activity)
Description
Evaluation of the level of physical activity by actimetry
Time Frame
12 months after consultation
Title
Assess the risk factors associated with OSA in patients treated with CPAP (blood pressure)
Description
Blood pressure by blood pressure monitoring at home
Time Frame
12 months after consultation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Apneic patient treated with CPAP for more than 12 months and having an annual scheduled follow-up visit.
Adult patient who can give an informed consent.
Patient with access to a media (Smartphone, tablet or computer) and an Internet connection at home.
Exclusion Criteria:
Patient unable to use or understand the digital system.
Patient under guardianship or deprived of liberty
Pregnant woman
Patient in a period of exclusion from another clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie JOYEUX-FAURE, Dr
Phone
+33 (0)4.76.76.71.66
Email
mjoyeuxfaure@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Renaud TAMISIER, Pr
Phone
+33 (0)4.76.76.84.69
Email
rtamisier@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud TAMISIER, Pr
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Grenoble-Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin TERRAIL
First Name & Middle Initial & Last Name & Degree
Renaud Tamisier
12. IPD Sharing Statement
Learn more about this trial
Follow-up of Apneic Patients by Visio-consultation
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