Follow-up of Apneic Patients by Visio-consultation
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Other: Videoconsultation
- Registration Number
- NCT04547543
- Lead Sponsor
- University Hospital, Grenoble
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Video consultation Videoconsultation Patients in this group will have a continuous positive pressure follow-up visit by videoconsultation
- Primary Outcome Measures
Name Time Method Consultation cost 3 months after consultation 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
Therapeutic adherence to CPAP 3 months after consultation 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
Patient satisfaction: questionnaire 3 months after consultation Non inferiority of visioconsultation compared to face-to-face consultation in terms of patient satisfaction evaluated by the VSQ-VF questionnaire
- Secondary Outcome Measures
Name Time Method Tiredness related to CPAP 3 and 12 months after consultation Pichot's fatigue scale
Sleepiness related to CPAP 3 and 12 after consultation Epworth Sleepiness Scale
Evaluate the quality of CPAP treatment (Residual AHI) 3 and 12 months after consultation Evaluate the quality of CPAP treatment by the residual Apnea-Hypopnea Index(AHI) (event/hour)
Evaluate the quality of CPAP treatment (adverse events) 3 and 12 months after consultation Evaluate the quality of CPAP treatment by the adverse event reporting
Evaluate the quality of CPAP treatment (mask leaks level) 3 and 12 months after consultation 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 3 and 12 months after consultation 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) 12 months after consultation Body weight (kg)
Assess the risk factors associated with OSA in patients treated with CPAP (blood pressure) 12 months after consultation Blood pressure by blood pressure monitoring at home
Assess the risk factors associated with OSA in patients treated with CPAP (level of physical activity) 12 months after consultation Evaluation of the level of physical activity by actimetry
Trial Locations
- Locations (1)
CHU Grenoble-Alpes
🇫🇷Grenoble, France