Obstructive Sleep Apnea
Conditions
Keywords
Telemedicine, Medical follow-up
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.
Interventions
OTHERVideoconsultation
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
Sponsors
University Hospital, Angers
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Sleepiness related to CPAP | 3 and 12 after consultation | Epworth Sleepiness Scale |
| 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 |
| 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 (weight) | 12 months after consultation | Body weight (kg) |
| Tiredness related to CPAP | 3 and 12 months after consultation | Pichot's fatigue 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) |
Countries
France
Contacts
Primary ContactMarie JOYEUX-FAURE, Dr
Backup ContactRenaud TAMISIER, Pr
Outcome results
None listed