Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05960175

Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP

Led by Asten Sante · Updated on 2025-08-11

556

Participants Needed

11

Research Sites

161 weeks

Total Duration

On this page

Sponsors

A

Asten Sante

Lead Sponsor

S

Slb Pharma

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult with newly diagnosed OSA (central apnea index <5 events/hour) and low sleepiness (Epworth score <11 at inclusion)
  • At least 1 cardiovascular risk factor (obesity, type I or II diabetes, permanent hypertension, heart failure with preserved ejection fraction, valve disease, history of atrial fibrillation, ischaemic heart disease, or stroke)
  • Owns a smartphone and agrees to use connected devices during the study
  • Signed informed consent form
  • Affiliated with a health insurance system or beneficiary
Not Eligible

You will not qualify if you...

  • Already fitted with a CPAP machine
  • Permanent atrial fibrillation
  • Unstable health or requires heavy treatment
  • Cognitive problems
  • Participating in another intervention research in pulmonology
  • Considered a vulnerable subject

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

CH Départemental Vendée

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

Actively Recruiting

2

AP-HP Hôpital Européen Georges

Paris, France, France, 75015

Actively Recruiting

3

CHU Angers - Service de pneumologie

Angers, France, 49100

Actively Recruiting

4

CHU Dijon-Bourgogne

Dijon, France, 21000

Actively Recruiting

5

CH Versailles

Le Chesnay, France, 78150

Actively Recruiting

6

CH Le Mans

Le Mans, France, 72037

Actively Recruiting

7

CHU Nancy

Nancy, France, 54511

Actively Recruiting

8

AP-HP Pitié Salpêtrière

Paris, France, 75013

Actively Recruiting

9

AP-HP Bichat Claude Bernard

Paris, France, 75018

Actively Recruiting

10

Polyclinique Saint-Laurent - Groupe médical de pneumologie

Rennes, France, 35000

Actively Recruiting

11

CHU Rouen - Charles Nicolle

Rouen, France, 76000

Actively Recruiting

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Research Team

A

Anne-Laure Sérandour

CONTACT

J

Johan Dupuis

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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