OSANCT05960175
Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP
A study testing New telemonitoring approach using 2 connected devices : Scanwatch connected watch + Asten&masanté application in people with OSA, run by Asten Sante at 11 sites in France.
Trial summary
Adherence to CPAP determines the expected benefits of the treatment. A dose-benefit relationship has been demonstrated for both functional and cardiovascular benefits. The first few days' use of the device are decisive in determining long-term compliance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSA
- What is being tested?
- New telemonitoring approach using 2 connected devices : Scanwatch connected watch + Asten&masanté application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 11 sitesFrance
- Study dates
- 29 Sep 2023to 28 Feb 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
- Adult with newly diagnosed OSA (with central apnea index <5 ev/h), justifying CPAP and with low sleepiness (Epworth score <11 at inclusion).
- Patient with at least 1 cardiovascular risk factor (obesity, type I or II diabetes with or without treatment, permanent hypertension with or without treatment, heart failure with preserved ejection fraction, valve disease, history of atrial fibrillation, history of ischaemic heart disease, history of stroke).
- Patient with a smartphone and who agrees to use connected objects during the study.
- Signed informed consent form,
- Subject affiliated to a health insurance system, or is a beneficiary.
Who cannot join
- Patients already fitted with a CPAP machine,
- Patients with permanent atrial fibrillation,
- Patients whose state of health is not stable or requires heavy treatment,
- Patients with cognitive problems.
- Patients participating in another intervention research in pulmonology.
- Vulnerable subject
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU Angers - Service de pneumologie
Angers, 49100
CHU Dijon-Bourgogne
Dijon, 21000
CH Départemental Vendée
La Roche-sur-Yon, France, 85925
CH Versailles
Le Chesnay, 78150
CH Le Mans
Le Mans, 72037
CHU Nancy
Nancy, 54511
AP-HP Hôpital Européen Georges
Paris, France, 75015
AP-HP Pitié Salpêtrière
Paris, 75013
AP-HP Bichat Claude Bernard
Paris, 75018
Polyclinique Saint-Laurent - Groupe médical de pneumologie
Rennes, 35000
CHU Rouen - Charles Nicolle
Rouen, 76000
About this study
Adherence to CPAP determines the expected benefits of the treatment. A dose-benefit relationship has been demonstrated for both functional and cardiovascular benefits. The first few days' use of the device are decisive in determining long-term compliance. In this context, daily monitoring of the data teletransmitted means that we can be more responsive to problems of compliance during the first few days of use; the contribution of telemonitoring can be very positive in a context of poor compliance.
In France, compulsory health insurance coverage of CPAP treatment is authorised for patients aged over 16 with clinical symptoms and an AHI ≥15 events per hour and <30 events/h in patients with severe cardiovascular co-morbidity. These patients are often not very sleepy due to sympathetic hypertonia with a shorter sleep duration. They are at high risk of non-compliance.
The IPIAM study specifically targets a population at cardiovascular risk and at high risk of non-compliance with CPAP treatment. The IPIAM study aims to involve patients in the success of their treatment via remote monitoring and to show that this approach makes it possible to improve the handling of alerts and to participate in the therapeutic support of the patient. Finally, this population also shares the risk of heart rhythm disorders. As part of a cross-disciplinary inter-pathology telemonitoring approach, it also makes sense to screen for cardiac rhythm disorders by wearing a connected watch.
Read the detailed description
IPIAM is a prospective randomized controled study with two arms. Two approaches to telemonitoring will be compared: the standard telemonitoring carried out by the home healthcare provider (standard of care) will be compared with a new approach in which the patient is involved in managing his treatment by collecting vitals and notifying alerts via two connected devices (a connected watch and a mobile application).
The study will comprise 2 phases :
- an initial interventional, comparative, randomised phase corresponding to the first 4 months of CPAP treatment,
- an observational period with standard telemonitoring, lasting until the 12th month of treatment.
In this study, all patients will be treated with the same continuous positive airway pressure ventilator (AirSense 11 Autoset, ResMed).
CPAP alerts will be checked by the home healthcare provider's technicians every week and then managed differently depending on the randomisation group.
Each patient will be seen twice in pulmonology consultations, once for the inclusion visit and once 4 months after CPAP initation.
- Conditions
- OSA
- Being tested
- New telemonitoring approach using 2 connected devices : Scanwatch connected watch + Asten&masanté application
- Keywords
- OSA, Cheyne-Stokes respiration (CSR), Continuous positive airway pressure (CPAP), Telemedicine
- Medical subject headings
- Cheyne-Stokes Respiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New telemonitoring approach using 2 connected devices : Scanwatch connected watch + Asten&masanté applicationDevice
The home healthcare provider will monitor the treatment remotely and make home visits, as in the control group. However, in the case of technical alerts concerning CPAP treatment (problems with observance, leaks, residual apneas), the provider will send the patient a notification via the mobile application in order to provide advice/instructions so that the patient can resolve the alert independently. The provider will monitor the resolution of alerts remotely and may contact the patient by telephone or come to your home if necessary.
If the connected watch detects an abnormal heart rhythm at night, the patient receives a notification and can undergo an electrocardiogram.
| Study group | Role | What they receive |
|---|---|---|
| Standard CPAP telemonitoring | No intervention | Patients are treated with CPAP and the home healthcare provider carries out monitoring in line with current practice (telemonitoring of treatment and regular home visits). |
| New CPAP telemonitoring approach | Experimental | Patients are treated with CPAP and the home healthcare provider is offering a new approach to remote monitoring in which patients are involved in managing their CPAP treatment using two connected devices (the Scanwatch connected watch + the mobile application Asten\&masanté) in the first 4 months of treatment. Receives: Device: New telemonitoring approach using 2 connected devices : Scanwatch connected watch + Asten&masanté application |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP treatment adherence
Measurement of the average daily duration of use of the CPAP (expressed in hours) over the last 30 nights, 4 months after initiation of treatment. The duration of use will be compared between both groups.
Measured: Month 4
Secondary outcomes (9)
Quality of CPAP treatment assessed by leaks
Measurement of the average leaks (expressed in liter per minute) per month using the daily data teletransmitted by CPAP ventilator throughout the follow-up period.
Measured: Month 1, Month 2, Month 3, Month 4
Quality of CPAP treatment assessed by apnea hypopnea index
Measurement of the average residual apnea hypopnea index (expressed in number of event per hour) per month using the daily data teletransmitted by CPAP ventilator throughout the follow-up period.
Measured: Month 1, Month 2, Month 3, Month 4
long term CPAP treatment adherence
Measurement of the average daily duration of use of the CPAP (expressed in hours) over the last 30 nights, 6 months and 1 year after initiation of treatment.
Measured: Month 6, Year 1
Number of nights with Cheynes Stoke Respirations (CSR)
Average number of nights with CSR per patient per 30-day period during the first 4 months of treatment.
Measured: over the first 4 months
Nocturnal heart rate
Night-time heart rate teletransmitted daily by the connected watch during the first 4 months, only in the experimental group.
Measured: over the first 4 months
Number of alerts
Average number of technical and medical alerts (related to adherence, leaks, apnea, CSR, increase in heart rate, atrial fibrillation) per patient per 30-day period during the first 4 months of treatment.
Measured: over the first 4 months
Number of medical events (pneumology and cardiology consultations, hospitalizations) related to OSA
Average number of medical events (pneumology and cardiology consultations, hospitalizations) related to OSA per patient
Measured: Month 4
F-SUS questionnaire
The French System Usability Scale (SUS) is a questionnaire evaluating the patient satisfaction on usability of interactive systems. The questionnaire comprises 10 questions and the score of user satisfaction varies from 0 to 100 (0 lowest score; 100 highest score).
Measured: Month 4
Number of home healthcare provider interventions
Average number of home healthcare provider interventions (phone call, home visit, remote assistance) per patient.
Measured: over the first 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start29 Sep 2023
- Primary completion28 Feb 2026
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 556 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asten Sante
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma, Nouvéal, Withings
- Responsible party
- Sponsor
- Investigators
- Arnaud Prigent, Dr, Principal investigator, Polyclinique Saint-Laurent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960175
- Sponsor's protocol ID
- IPIAM
- Status last verified
- Jun 2026
- First submitted
- 11 Jul 2023
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP
- ClinicalTrials.gov ID
- NCT05960175
- Acronym / sponsor ID
- IPIAM
- Conditions
- OSA
- Keywords
- OSA, Cheyne-Stokes respiration (CSR), Continuous positive airway pressure (CPAP), Telemedicine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Asten SanteIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma, Nouvéal, Withings
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 25 Jul 2023 (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.
Adherence to CPAP determines the expected benefits of the treatment. A dose-benefit relationship has been demonstrated for both functional and cardiovascular benefits. The first few days' use of the device are decisive in determining long-term compliance. In this context, daily monitoring of the data teletransmitted means that we can be more responsive to problems of compliance during the first few days of use; the contribution of telemonitoring can be very positive in a context of poor compliance.
In France, compulsory health insurance coverage of CPAP treatment is authorised for patients aged over 16 with clinical symptoms and an AHI ≥15 events per hour and <30 events/h in patients with severe cardiovascular co-morbidity. These patients are often not very sleepy due to sympathetic hypertonia with a shorter sleep duration. They are at high risk of non-compliance.
The IPIAM study specifically targets a population at cardiovascular risk and at high risk of non-compliance with CPAP treatment. The IPIAM study aims to involve patients in the success of their treatment via remote monitoring and to show that this approach makes it possible to improve the handling of alerts and to participate in the therapeutic support of the patient. Finally, this population also shares the risk of heart rhythm disorders. As part of a cross-disciplinary inter-pathology telemonitoring approach, it also makes sense to screen for cardiac rhythm disorders by wearing a connected watch.
Detailed description
IPIAM is a prospective randomized controled study with two arms. Two approaches to telemonitoring will be compared: the standard telemonitoring carried out by the home healthcare provider (standard of care) will be compared with a new approach in which the patient is involved in managing his treatment by collecting vitals and notifying alerts via two connected devices (a connected watch and a mobile application).
The study will comprise 2 phases :
- an initial interventional, comparative, randomised phase corresponding to the first 4 months of CPAP treatment,
- an observational period with standard telemonitoring, lasting until the 12th month of treatment.
In this study, all patients will be treated with the same continuous positive airway pressure ventilator (AirSense 11 Autoset, ResMed).
CPAP alerts will be checked by the home healthcare provider's technicians every week and then managed differently depending on the randomisation group.
Each patient will be seen twice in pulmonology consultations, once for the inclusion visit and once 4 months after CPAP initation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard CPAP telemonitoring | No intervention | –Patients are treated with CPAP and the home healthcare provider carries out monitoring in line with current practice (telemonitoring of treatment and regular home visits). |
| New CPAP telemonitoring approach | Experimental | Device: New telemonitoring approach using 2 connected devices : Scanwatch connected watch + Asten&masanté applicationPatients are treated with CPAP and the home healthcare provider is offering a new approach to remote monitoring in which patients are involved in managing their CPAP treatment using two connected devices (the Scanwatch connected watch + the mobile application Asten\&masanté) in the first 4 months of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult with newly diagnosed OSA (with central apnea index <5 ev/h), justifying CPAP and with low sleepiness (Epworth score <11 at inclusion).
- Patient with at least 1 cardiovascular risk factor (obesity, type I or II diabetes with or without treatment, permanent hypertension with or without treatment, heart failure with preserved ejection fraction, valve disease, history of atrial fibrillation, history of ischaemic heart disease, history of stroke).
- Patient with a smartphone and who agrees to use connected objects during the study.
- Signed informed consent form,
- Subject affiliated to a health insurance system, or is a beneficiary.
Key exclusion criteria (6 listed)
- Patients already fitted with a CPAP machine,
- Patients with permanent atrial fibrillation,
- Patients whose state of health is not stable or requires heavy treatment,
- Patients with cognitive problems.
- Patients participating in another intervention research in pulmonology.
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 |
|---|---|---|
| New telemonitoring approach using 2 connected devices : Scanwatch connected watch + Asten&masanté applicationThe home healthcare provider will monitor the treatment remotely and make home visits, as in the control group. However, in the case of technical alerts concerning CPAP treatment (problems with observance, leaks, residual apneas), the provider will send the patient a notification via the mobile application in order to provide advice/instructions so that the patient can resolve the alert independently. The provider will monitor the resolution of alerts remotely and may contact the patient by telephone or come to your home if necessary. If the connected watch detects an abnormal heart rhythm at night, the patient receives a notification and can undergo an electrocardiogram. | Device | New CPAP telemonitoring approach |
Primary outcome
CPAP treatment adherence
Time frame: Month 4
Measurement of the average daily duration of use of the CPAP (expressed in hours) over the last 30 nights, 4 months after initiation of treatment. The duration of use will be compared between both groups.
9 secondary outcomes
Quality of CPAP treatment assessed by leaks
Time frame: Month 1, Month 2, Month 3, Month 4
Quality of CPAP treatment assessed by apnea hypopnea index
Time frame: Month 1, Month 2, Month 3, Month 4
long term CPAP treatment adherence
Time frame: Month 6, Year 1
Number of nights with Cheynes Stoke Respirations (CSR)
Time frame: over the first 4 months
Nocturnal heart rate
Time frame: over the first 4 months
Number of alerts
Time frame: over the first 4 months
Number of medical events (pneumology and cardiology consultations, hospitalizations) related to OSA
Time frame: Month 4
F-SUS questionnaire
Time frame: Month 4
Number of home healthcare provider interventions
Time frame: over the first 4 months
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 26 Jun 2026.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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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.
Arnaud Prigent, Dr principal investigator
Polyclinique Saint-Laurent
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New telemonitoring approach using 2 connected devices : Scanwatch connected watch + Asten&masanté application in people with OSA, run by Asten Sante at 11 sites 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 5 inclusion and 6 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 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
CPAP treatment adherence (time frame: Month 4). 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 26 Jun 2026.