Follow-up of Apneic Patients by Visio-consultation

Obstructive Sleep Apnea Clinical Trial

— VISIOSAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04547543
• Other study ID #: 38RC19.312
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: March 2026

Study information

• Verified date: January 2024
• Source: University Hospital, Grenoble
• Contact: Marie JOYEUX-FAURE, Dr
• Phone: +33 (0)4.76.76.71.66
• Email: mjoyeuxfaure[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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 information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Other:
• Videoconsultation
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

Locations

Country	Name	City	State
France	CHU Grenoble-Alpes	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Sleepiness related to CPAP	Epworth Sleepiness Scale	3 and 12 after consultation
Secondary	Tiredness related to CPAP	Pichot's fatigue scale	3 and 12 months after consultation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Assess the risk factors associated with OSA in patients treated with CPAP (weight)	Body weight (kg)	12 months after consultation
Secondary	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
Secondary	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