The TELEAP1 CPAP-telemonitoring Study

NCT ID: NCT04897646

Last Updated: 2021-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-12-15

Brief Summary

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TELEAP1 is a multicenter cohort pilot-study designed to evaluate the impact of a published SFRMS/SPLF CPAP-telemonitoring diagnosis/therapeutic algorithm on the CPAP-compliance of newly treated patients with obstructive sleep apnea..

Detailed Description

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Continuous Positive Airway Pressure (CPAP)-devices can track compliance, but also leaks and residual Apnea-Hypopnea-Index (AHIflow) values. CPAP tracking systems seem intuitively useful, but there are few data demonstrating the benefit of such systems in improving CPAP-compliance and/or patients quality of life.

In 2020, a working group from the Société Française de Recherche et de Médecine du Sommeil (SFRMS) and the Société de Pneumologie de Langue Française (SPLF) have proposed a CPAP-telemonitoring diagnosis/therapeutic algorithm for newly treated patients with obstructive sleep apnea.

In order to describe and evaluate the impact of this SFRMS/SPLF-algorithm (not only on the patient but also on the home care provider activity), a one year multicenter cohort pilot-study (TELAP1-study) was set up.

Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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SFRMS/SPLF CPAP-telemonitoring diagnosis/therapeutic algorithm.

In 2020, a working group from the Société Française de Recherche et de Médecine du Sommeil (SFRMS) and the Société de Pneumologie de Langue Française (SPLF) have proposed a CPAP-telemonitoring diagnosis/therapeutic algorithm for newly treated patients with obstructive sleep apnea.

The algorithm is exhasutively described in the following published article: Prigent, A., Gentina, T., Launois, S., et al. \[Telemonitoring in continuous positive airway pressure-treated patients with obstructive sleep apnoea syndrome: An algorithm proposal\]. Rev. Mal. Respir., 2020, 37: 550-560.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Patient newly CPAP-treated and eligible for care and for the reimbursement by the French Social Security rules
* Signed informed consent

Exclusion Criteria

* Previous CPAP-treatment
* Pregnancy
* Inability to understand the nature and aims of the study or to communicate with the investigator
* Simultaneous participation in another trial with an exclusion clause to participate in another trial
* No affiliation with the French social security regime
* Loss of personal capacity resulting in state protection
* Deprivation of liberty by judicial or administrative decision
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ADENE, Montpellier

UNKNOWN

Sponsor Role collaborator

AGIR à dom, Meylan

UNKNOWN

Sponsor Role collaborator

ASTEN sante, Pays de la Loire

UNKNOWN

Sponsor Role collaborator

ELIA medical, Cesson-Sévigné

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dany Jaffuel, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Montpellier University Hospitals

Fréderic Gagnadoux

Role: STUDY_DIRECTOR

University Hospital, Angers

Arnaud Prigent

Role: PRINCIPAL_INVESTIGATOR

Polyclinique Saint Laurent - Rennes

Renaud Tamisier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Uhmontpellier

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Dany Jaffuel, MD, PhD

Role: CONTACT

+33467314840

Arnaud Prigent, MD

Role: CONTACT

Facility Contacts

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Dany Jaffuel, MD, PhD

Role: primary

4 67 33 63 03 ext. 33

Other Identifiers

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RECHMPL21_0082

Identifier Type: -

Identifier Source: org_study_id

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