Obstructive Sleep ApneaVISIOSASNCT04547543
Follow-up of Apneic Patients by Visio-consultation
A study testing Videoconsultation in people with Obstructive Sleep Apnea, run by University Hospital, Grenoble at 1 site in France.
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) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Videoconsultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2020to 5 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visio-consultation Compared to Face-to-face Consultation During the Follow-up of Apneic Patients Treated by Continuous Positive Airway Pressure (CPAP)
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) .
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Videoconsultation
- Keywords
- Telemedicine, Medical follow-up
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoconsultationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Video consultation | Other | Patients in this group will have a continuous positive pressure follow-up visit by videoconsultation Receives: Other: Videoconsultation |
| Face-to-face consultation | No intervention | Patients in this group will have a continuous positive pressure follow-up visit by face-to-face consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 months after consultation
Secondary outcomes (9)
Sleepiness related to CPAP
Epworth Sleepiness Scale
Measured: 3 and 12 after consultation
Tiredness related to CPAP
Pichot's fatigue scale
Measured: 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)
Measured: 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
Measured: 3 and 12 months after consultation
Evaluate the quality of CPAP treatment (mask leaks level)
Evaluate the quality of CPAP treatment by the CPAP mask leaks level (litre/min)
Measured: 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
Measured: 3 and 12 months after consultation
Assess the risk factors associated with OSA in patients treated with CPAP (weight)
Body weight (kg)
Measured: 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
Measured: 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
Measured: 12 months after consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start8 Sep 2020
- Primary completion30 Sep 2025
- Study completion5 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Angers
- Responsible party
- Sponsor
- Investigators
- Renaud TAMISIER, Pr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547543
- Sponsor's protocol ID
- 38RC19.312
- Acronym
- VISIOSAS
- Status last verified
- Oct 2026
- First submitted
- 7 Sep 2020
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No