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) .
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
250
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
CHU Grenoble-Alpes
Grenoble, France
RECRUITINGTherapeutic 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
Time frame: 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
Time frame: 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
Time frame: 3 months after consultation
Sleepiness related to CPAP
Epworth Sleepiness Scale
Time frame: 3 and 12 after consultation
Tiredness related to CPAP
Pichot's fatigue scale
Time frame: 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)
Time frame: 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
Time frame: 3 and 12 months after consultation
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Evaluate the quality of CPAP treatment (mask leaks level)
Evaluate the quality of CPAP treatment by the CPAP mask leaks level (litre/min)
Time frame: 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
Time frame: 3 and 12 months after consultation
Assess the risk factors associated with OSA in patients treated with CPAP (weight)
Body weight (kg)
Time frame: 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
Time frame: 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
Time frame: 12 months after consultation