An interventional study of New telemonitoring approach using 2 connected devices : Scanwatch connected watch + Asten&masanté application in OSA, sponsored by Asten Sante. Active, not recruiting at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Asten Sante · Not applicable, Interventional, and Treatment
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.
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 :
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.
23 studies on the registry are indexed under Cheyne-Stokes Respiration; 1 is open to participants now.
This study's planned enrollment of 556 is above the median of 48 across 20 interventional studies indexed under Cheyne-Stokes Respiration.
Browse Cheyne-Stokes Respiration studies →Asten Sante is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
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.
Device: New telemonitoring approach using 2 connected devices : Scanwatch connected watch + Asten&masanté application
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.
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.
Time frame: Month 4
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: Month 4
Number of home healthcare provider interventions
Average number of home healthcare provider interventions (phone call, home visit, remote assistance) per patient.
Time frame: over the first 4 months
Plan to share: No
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This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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