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
- Are there results?
- None posted in the registry
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.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visio-consultation Compared to Face-to-face Consultation During the Follow-up of Apneic Patients Treated by Continuous Positive Airway Pressure (CPAP)
- ClinicalTrials.gov ID
- NCT04547543
- Acronym / sponsor ID
- VISIOSAS / 38RC19.312
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Telemedicine, Medical follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Hospital, Angers
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 5 Aug 2026 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video consultation | Other | Other: VideoconsultationPatients in this group will have a continuous positive pressure follow-up visit by 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideoconsultationPatient 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 | Other | Video consultation |
Primary outcome
Therapeutic adherence to CPAP
Time frame: 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
Time frame: 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
Time frame: 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
9 secondary outcomes
Sleepiness related to CPAP
Time frame: 3 and 12 after consultation
Tiredness related to CPAP
Time frame: 3 and 12 months after consultation
Evaluate the quality of CPAP treatment (Residual AHI)
Time frame: 3 and 12 months after consultation
Evaluate the quality of CPAP treatment (adverse events)
Time frame: 3 and 12 months after consultation
Evaluate the quality of CPAP treatment (mask leaks level)
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
Time frame: 3 and 12 months after consultation
Assess the risk factors associated with OSA in patients treated with CPAP (weight)
Time frame: 12 months after consultation
Assess the risk factors associated with OSA in patients treated with CPAP (level of physical activity)
Time frame: 12 months after consultation
Assess the risk factors associated with OSA in patients treated with CPAP (blood pressure)
Time frame: 12 months after consultation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renaud TAMISIER, Pr principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videoconsultation in people with Obstructive Sleep Apnea, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic adherence to CPAP (time frame: 3 months after consultation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.