Follow-up of Apneic Patients by Visio-consultation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Other: Videoconsultation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Medical follow-up