Clinical trial NCT04547543: Follow-up of Apneic Patients by Visio-consultation
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
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Telemedicine
Medical follow-up
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Hospital, Angers
First posted: 2020-09-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Therapeutic adherence to CPAP
timeFrame: 3 months after consultation
measure: Consultation cost
timeFrame: 3 months after consultation
measure: Patient satisfaction: questionnaire
timeFrame: 3 months after consultation
Secondary outcomes:
measure: Sleepiness related to CPAP
timeFrame: 3 and 12 after consultation
measure: Tiredness related to CPAP
timeFrame: 3 and 12 months after consultation
measure: Evaluate the quality of CPAP treatment (Residual AHI)
timeFrame: 3 and 12 months after consultation
measure: Evaluate the quality of CPAP treatment (adverse events)
timeFrame: 3 and 12 months after consultation
measure: Evaluate the quality of CPAP treatment (mask leaks level)
timeFrame: 3 and 12 months after consultation
measure: 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
timeFrame: 3 and 12 months after consultation
measure: Assess the risk factors associated with OSA in patients treated with CPAP (weight)
timeFrame: 12 months after consultation
measure: Assess the risk factors associated with OSA in patients treated with CPAP (level of physical activity)
timeFrame: 12 months after consultation
measure: Assess the risk factors associated with OSA in patients treated with CPAP (blood pressure)
timeFrame: 12 months after consultation
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble-Alpes
Study officials:
affiliation: University Hospital, Grenoble
name: Renaud TAMISIER, Pr
role: PRINCIPAL_INVESTIGATOR
References: