Obstructive Sleep Apneai-tech PPCNCT05653804
Impact of Tele-visit on Patients Continous Positive Airway Pressure (CPAP) Follow-up by Home Care Provider
A study testing tele-visit in people with Obstructive Sleep Apnea, run by AGIR à Dom at 1 site in France.
Trial summary
To determine the impact of telecare on continous positive airway pressure (CPAP) patients follow up by home care provider (HCP) 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?
- tele-visit
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2023to 11 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- CPAP ≥ 12 months and annual followed by "AGIR à dom" health care provider.
- Compliance with CPAP ≥ 4h/night and AHI ≤ 5 events/hour on machine report for the 3 months prior to inclusion
Who cannot join
- Follow-up by AGIR à dom. for an other service than package F9.1 : CPAP follow-up and remote monitoring
- Unacceptable level of mask leakage
- Patient unavailable or willing to move within the next 12 months to an area not covered by AGIR à dom.
- Patient considered by the investigator to be unfit for a tele-visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Tele-visit Versus Home Visit by Home Care Provider on Compliance With Continuous Positive Airway Pressure (CPAP) Therapy of Patients With Obstructive Sleep Apnea Syndrome
To determine the impact of telecare on continous positive airway pressure (CPAP) patients follow up by home care provider (HCP)
Read the detailed description
Obstructive sleep apnea (OSA) syndrome is a chronic respiratory pathology affecting 4% of french adult population and reference treatment for moderate to severe forms of obstructive sleep apnea syndrome (OSA) is continuous positive airway pressure (CPAP).
However, CPAP treatment is binding, so nearly a quarter of patients abandoning treatment at 1 year and nearly half of them at 3 years. Support for these patients on CPAP must therefore be optimal and seek patient satisfaction; HCP (Home Care Provider) plays an important role in this follow-up.
Since 2018 in France, teleconsultation entered on common law but was little used. The pandemic has disrupted the habits of care and patients monitoring by developing remote monitoring. Home Care Providers (HCP) have also been forced to organize remote monitoring, particularly for the annual follow-up visit (technical tele-visit).
The impact of the annual follow-up visits of HCP by tele-visit has never been clinically evaluated. If its clinical relevance were demonstrated and patient satisfaction confirmed, this follow-up modality could become, like telecare, a new standard for the follow-up of patients on CPAP.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- tele-visit
- Keywords
- tele-visit
- 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.
tele-visitProcedure or surgery
The remote visit content for CPAP follow up is based on home visit framework and carried out from a secure platform for sharing health data.
| Study group | Role | What they receive |
|---|---|---|
| tele-visit by HCP | Experimental | Patients receive a annual CPAP remote visit by HCP technician, then home visit the following year Receives: Procedure: tele-visit |
| home visit by HCP | No intervention | Standard care : patients receive an annual CPAP home visit by HCP technician |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare CPAP compliance between the two management modalities
CPAP mean compliance between intervention and control groups, adjusted for the three months prior to inclusion : in hours/day, collected on the CPAP remote monitoring report
Measured: Over the 3 months (tele)visit follow-up
Secondary outcomes (13)
To compare overall patient satisfaction between the two management modalities
The Consumer Satisfaction Questionnaire (CSQ-8) mean score between intervention and control groups, after the CPAP (tele-)visit follow-up .
The overall score is calculated by adding the respondent's evaluation score (item evaluation) for each item on the scale. For the CSQ-8 version, the scores therefore range from 8 to 32, with higher values indicating greater satisfaction.
Measured: Immediately after the (tele-)visit follow-up
To compare the impact on daytime sleepiness between the two management modalities
Epworth Sleepiness Scale (ESS) mean score between intervention and control group.
All items are assumed to be integers (0-3). The ESS score is the sum of 8 item scores.
0-10 = normal range of sleepiness in healthy adults 11 to 14 = mild sleepiness 15 to 17 = moderate sleepiness 18 to 24 = severe sleepiness
Measured: At 3 months after (tele-)visit follow-up
To compare impact on quality of life between the two management modalities
The EuroQol 5 Dimensions - 5 levels (EQ5D-5L) questionnaire mean score between intervention and control group, adjusted on the baseline score.
it's composed of two parts : A visual analog scale (20 cm line, graduated from 0 to 100 where patient indicates his or her current state of health, 0 being the worst and 100 the best)
the completion of 5 items evaluating mobility, autonomy, daily activities, pain or discomfort and anxiety or depression.
- indicating no problem
- indicating slight problems
- indicating moderate problems
- indicating severe problems
- indicating unable to/extreme problems Each state is referred to by a 5-digit code.
Measured: At 3 months after (tele-)visit follow-up
To compare CPAP compliance in medium term between the two management modalities
CPAP mean compliance between intervention and control group : in hours/day, collected on the CPAP remote monitoring report
Measured: Over the 12 months (tele)visit follow-up
To compare impact on CPAP continuation between the two management modalities
Rate of CPAP removal between intervention and control group ; the number of CPAP unbundling among participants
Measured: Over the 12 months (tele)visit follow-up
To compare treatment effectiveness between the two management modalities
Apnea Hypopnea Index (AHI) mean between intervention and control group. AHI corresponds to the number of apneas and hypopneas per hour of sleep, collected on the CPAP remote monitoring report.
Measured: Over the 12 months (tele)visit follow-up
To compare treatment quality on mask leakage between the two management modalities
Leakage mean level between intervention and control group
Measured: Over the 3 months (tele)visit follow-up
To compare occurrence frequency of CPAP-related adverse effect(s) between the two management modalities
The Side-Effects to CPAP treatment Inventory (SECI) mean score between the intervention and control group.
Each of the 15 items relating to side effects associated with CPAP treatment has three subscales: frequency, breadth of the side effect, and impact on CPAP use.
For each subscale, the patient will complete a five-point Likert-type scale, so the possible range for each subscale is 15 to 75.
A higher score indicates greater frequency of side effects, greater breadth of side effects, and greater intensity of side effects.
Measured: Over the 3 months (tele)visit follow-up
To compare follow-up impact in addition to the annual visit between the two management modalities
Mean number of calls and visits made per patient between control and intervention group
Measured: Over the 12 months (tele)visit follow-up
To evaluate failed visits number between the two care modalities
Mean number of (tele-)visits requiring a reprogramming (absence, technical problem, last minute deprogramming, home visit...)
Measured: Over the 12 months (tele)visit follow-up
To evaluate patient satisfaction with tele-visits
The Televisit Satisfaction Questionnaire (TSQ) mean score
14 items, rated between 1 and 5 by the patient. The sum of the items corresponds to a score ranging from 14 to 70.
Measured: Immediately after the (tele-)visit follow-up
To evaluate technician satisfaction with tele-visits
The Televisit Satisfaction Questionnaire (TSQ) questionnaire mean score
14 items, rated between 1 and 5 by the patient. The sum of the items corresponds to a score ranging from 14 to 70.
Measured: Immediately after the (tele-)visit follow-up
Comparison of the environmental impact associated with the two patient follow-up methods (home visit versus tele-visit)
Comparison of the carbon emissions generated by each care modality, calculated over the entire patient participation period and expressed in kgCO₂e, considering only the impact of the follow-up method itself, without including the individual use of the CPAP device.
Measured: Over the 12 months (tele)visit follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Apr 2023
- Primary completion11 May 2026 (estimated)
- Study completion11 May 2027 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, interventional, randomized controlled, open-label, single-center, multi-site
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGIR à Dom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Christian BOREL, PhD, Principal investigator, AGIR à Dom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653804
- Sponsor's protocol ID
- 2022-A02309-34
- Acronym
- i-tech PPC
- Status last verified
- Feb 2026
- First submitted
- 18 Nov 2022
- Last updated
- 12 Feb 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tele-visit Versus Home Visit by Home Care Provider on Compliance With Continuous Positive Airway Pressure (CPAP) Therapy of Patients With Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT05653804
- Acronym / sponsor ID
- i-tech PPC / 2022-A02309-34
- Conditions
- Obstructive Sleep Apnea
- Keywords
- tele-visit
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (actual)
- Lead sponsor
- AGIR à DomUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 11 May 2026 (estimated)
- Study completion
- 11 May 2027 (estimated)
- First posted
- 16 Dec 2022 (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.
To determine the impact of telecare on continous positive airway pressure (CPAP) patients follow up by home care provider (HCP)
Detailed description
Obstructive sleep apnea (OSA) syndrome is a chronic respiratory pathology affecting 4% of french adult population and reference treatment for moderate to severe forms of obstructive sleep apnea syndrome (OSA) is continuous positive airway pressure (CPAP).
However, CPAP treatment is binding, so nearly a quarter of patients abandoning treatment at 1 year and nearly half of them at 3 years. Support for these patients on CPAP must therefore be optimal and seek patient satisfaction; HCP (Home Care Provider) plays an important role in this follow-up.
Since 2018 in France, teleconsultation entered on common law but was little used. The pandemic has disrupted the habits of care and patients monitoring by developing remote monitoring. Home Care Providers (HCP) have also been forced to organize remote monitoring, particularly for the annual follow-up visit (technical tele-visit).
The impact of the annual follow-up visits of HCP by tele-visit has never been clinically evaluated. If its clinical relevance were demonstrated and patient satisfaction confirmed, this follow-up modality could become, like telecare, a new standard for the follow-up of patients on CPAP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, interventional, randomized controlled, open-label, single-center, multi-site
| Arm | Type | Receives |
|---|---|---|
| tele-visit by HCP | Experimental | Procedure: tele-visitPatients receive a annual CPAP remote visit by HCP technician, then home visit the following year |
| home visit by HCP | No intervention | –Standard care : patients receive an annual CPAP home visit by HCP technician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- CPAP ≥ 12 months and annual followed by "AGIR à dom" health care provider.
- Compliance with CPAP ≥ 4h/night and AHI ≤ 5 events/hour on machine report for the 3 months prior to inclusion
Key exclusion criteria (4 listed)
- Follow-up by AGIR à dom. for an other service than package F9.1 : CPAP follow-up and remote monitoring
- Unacceptable level of mask leakage
- Patient unavailable or willing to move within the next 12 months to an area not covered by AGIR à dom.
- Patient considered by the investigator to be unfit for a tele-visit
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 |
|---|---|---|
| tele-visitThe remote visit content for CPAP follow up is based on home visit framework and carried out from a secure platform for sharing health data. | Procedure or surgery | tele-visit by HCP |
Primary outcome
To compare CPAP compliance between the two management modalities
Time frame: Over the 3 months (tele)visit follow-up
CPAP mean compliance between intervention and control groups, adjusted for the three months prior to inclusion : in hours/day, collected on the CPAP remote monitoring report
13 secondary outcomes
To compare overall patient satisfaction between the two management modalities
Time frame: Immediately after the (tele-)visit follow-up
To compare the impact on daytime sleepiness between the two management modalities
Time frame: At 3 months after (tele-)visit follow-up
To compare impact on quality of life between the two management modalities
Time frame: At 3 months after (tele-)visit follow-up
To compare CPAP compliance in medium term between the two management modalities
Time frame: Over the 12 months (tele)visit follow-up
To compare impact on CPAP continuation between the two management modalities
Time frame: Over the 12 months (tele)visit follow-up
To compare treatment effectiveness between the two management modalities
Time frame: Over the 12 months (tele)visit follow-up
To compare treatment quality on mask leakage between the two management modalities
Time frame: Over the 3 months (tele)visit follow-up
To compare occurrence frequency of CPAP-related adverse effect(s) between the two management modalities
Time frame: Over the 3 months (tele)visit follow-up
To compare follow-up impact in addition to the annual visit between the two management modalities
Time frame: Over the 12 months (tele)visit follow-up
To evaluate failed visits number between the two care modalities
Time frame: Over the 12 months (tele)visit follow-up
To evaluate patient satisfaction with tele-visits
Time frame: Immediately after the (tele-)visit follow-up
To evaluate technician satisfaction with tele-visits
Time frame: Immediately after the (tele-)visit follow-up
Comparison of the environmental impact associated with the two patient follow-up methods (home visit versus tele-visit)
Time frame: Over the 12 months (tele)visit follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Jean Christian BOREL, PhD principal investigator
AGIR à Dom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tele-visit in people with Obstructive Sleep Apnea, run by AGIR à Dom 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 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?
This study is still under way. Results are not available in the source record yet.
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?
To compare CPAP compliance between the two management modalities (time frame: Over the 3 months (tele)visit follow-up). 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 12 Feb 2026.