Clinical trial NCT04897646: The TELEAP1 CPAP-telemonitoring Study
Official title: Evaluation of a CPAP Telemonitoring Algorithm for Newly Treated Patients: the TELEAP1 Multicenter Cohort Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep apnea
Continuous Positive Airway Pressure,
Telemedicine
COVID 19
observance
leaks
apnea hypopnea index.
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: ADENE, Montpellier
name: AGIR à dom, Meylan
name: ASTEN sante, Pays de la Loire
name: ELIA medical, Cesson-Sévigné
First posted: 2021-05-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients included in the study are newly CPAP-treated with a diagnosis of obstructive sleep apnea.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: CPAP-complianceversus corresponding 2019 weeks (h/days)
timeFrame: 4 months
Secondary outcomes:
measure: AHIflow
timeFrame: 4 months
measure: CPAP-adherence
timeFrame: 12 months
measure: CPAP-leaks
timeFrame: 4 months
measure: CPAP-leaks
timeFrame: 12 months
measure: Patient subjective sleepiness
timeFrame: 4 months
measure: Patient subjective sleepiness
timeFrame: 12 months
measure: Patient subjective depression
timeFrame: 12 months
measure: Patient subjective insomnia
timeFrame: 4 months
measure: Patient subjective insomnia
timeFrame: 12 months
measure: CPAP-compliance
timeFrame: 12 months
measure: Unplanned patient phone call
timeFrame: Day 0 to 360
measure: Unplanned technician phone call
timeFrame: Day 0 to 360
measure: Unplanned patient visit
timeFrame: Day 0 to 360
measure: Unplanned technician visit
timeFrame: Day 0 to 360
measure: CPAP telemonitoring alarm
timeFrame: Day 0 to 360
measure: Interface-type change
timeFrame: Day 0 to 360
measure: Pressure settings modification
timeFrame: Day 0 to 360
measure: CPAP-mode modification
timeFrame: Day 0 to 360
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: Montpellier University Hospitals
name: Dany Jaffuel, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Angers
name: Fréderic Gagnadoux
role: STUDY_DIRECTOR
affiliation: Polyclinique Saint Laurent - Rennes
name: Arnaud Prigent
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Grenoble
name: Renaud Tamisier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: