Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP

NCT05960175 | Recruiting

• 1 other identifier: IPIAM
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 11

Brief 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. 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.

Conditions

OSA

Keywords

OSA; Cheyne-Stokes respiration (CSR); Continuous positive airway pressure (CPAP); Telemedicine

Outcome Measures

Primary Outcomes (1)

• 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.

  Month 4

Secondary Outcomes (9)

• Quality of CPAP treatment assessed by leaks

  Month 1, Month 2, Month 3, Month 4

• Quality of CPAP treatment assessed by apnea hypopnea index

  Month 1, Month 2, Month 3, Month 4

• long term CPAP treatment adherence

  Month 6, Year 1

• Number of nights with Cheynes Stoke Respirations (CSR)

  over the first 4 months

• Nocturnal heart rate

  over the first 4 months

Study Arms (2)

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.

Device: New telemonitoring approach using 2 connected devices : Scanwatch connected watch + Asten&masanté application

Interventions

New telemonitoring approach using 2 connected devices : Scanwatch connected watch + Asten&masanté application DEVICE

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.

New CPAP telemonitoring approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asten Sante: lead
• Slb Pharma: collaborator
• Nouvéal: collaborator
• Withings: collaborator

Study Sites (11)

CH Départemental Vendée

La Roche-sur-Yon, France, 85925, France

RECRUITING

AP-HP Hôpital Européen Georges

Paris, France, 75015, France

RECRUITING

CHU Angers - Service de pneumologie

Angers, 49100, France

RECRUITING

CHU Dijon-Bourgogne

Dijon, 21000, France

RECRUITING

CH Versailles

Le Chesnay, 78150, France

RECRUITING

CH Le Mans

Le Mans, 72037, France

RECRUITING

CHU Nancy

Nancy, 54511, France

RECRUITING

AP-HP Pitié Salpêtrière

Paris, 75013, France

RECRUITING

AP-HP Bichat Claude Bernard

Paris, 75018, France

RECRUITING

Polyclinique Saint-Laurent - Groupe médical de pneumologie

Rennes, 35000, France

RECRUITING

CHU Rouen - Charles Nicolle

Rouen, 76000, France

RECRUITING

MeSH Terms

Conditions

Cheyne-Stokes Respiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnaud Prigent, Dr

  Polyclinique Saint-Laurent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Laure Sérandour

CONTACT

+33 2 99 12 19 62; al.serandour@slbpharma.com

Johan Dupuis

CONTACT

+33 7 89 20 75 33; jdupuis@astensante.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 25, 2023
• Study Start: September 29, 2023
• Primary Completion: January 31, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)