Follow-up of Apneic Patients by Visio-consultation (VISIOSAS)

Visio-consultation Compared to Face-to-face Consultation During the Follow-up of Apneic Patients Treated by Continuous Positive Airway Pressure (CPAP)

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) .

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: Videoconsultation

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie JOYEUX-FAURE, Dr; Phone Number: +33 (0)4.76.76.71.66; Email: mjoyeuxfaure@chu-grenoble.fr
• Study Contact Backup: Name: Renaud TAMISIER, Pr; Phone Number: +33 (0)4.76.76.84.69; Email: rtamisier@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France, 38043
    • Recruiting
    • CHU Grenoble-Alpes
    • Contact: Robin TERRAIL
    • Principal Investigator: Renaud Tamisier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Video consultation; Patients in this group will have a continuous positive pressure follow-up visit by videoconsultation	Other: Videoconsultation; 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
No Intervention: Face-to-face consultation; Patients in this group will have a continuous positive pressure follow-up visit by face-to-face consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months after 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	3 months after 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	3 months after consultation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleepiness related to CPAP	Epworth Sleepiness Scale	3 and 12 after consultation
Tiredness related to CPAP	Pichot's fatigue scale	3 and 12 months after consultation
Evaluate the quality of CPAP treatment (Residual AHI)	Evaluate the quality of CPAP treatment by the residual Apnea-Hypopnea Index(AHI) (event/hour)	3 and 12 months after consultation
Evaluate the quality of CPAP treatment (adverse events)	Evaluate the quality of CPAP treatment by the adverse event reporting	3 and 12 months after consultation
Evaluate the quality of CPAP treatment (mask leaks level)	Evaluate the quality of CPAP treatment by the CPAP mask leaks level (litre/min)	3 and 12 months after consultation
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	3 and 12 months after consultation
Assess the risk factors associated with OSA in patients treated with CPAP (weight)	Body weight (kg)	12 months after consultation
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	12 months after consultation
Assess the risk factors associated with OSA in patients treated with CPAP (blood pressure)	Blood pressure by blood pressure monitoring at home	12 months after consultation

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: University Hospital, Angers
• Investigators: Principal Investigator: Renaud TAMISIER, Pr, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Telemedicine; Medical follow-up
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 38RC19.312

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No