The TELEAP1 CPAP-telemonitoring Study

University Hospital, Montpellier300 enrolled

Overview

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..

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Obstructive Sleep Apnea

Interventions

SFRMS/SPLF CPAP-telemonitoring diagnosis/therapeutic algorithm.OTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Uhmontpellier

Montpellier, France

RECRUITING

Outcomes

Primary Outcomes

CPAP-complianceversus corresponding 2019 weeks (h/days)

CPAP-compliance (hour/day) reported by the CPAP-software for the last 28 days

Time frame: 4 months

Secondary Outcomes

AHIflow

AHIflow (events/hour) reported by the CPAP-software for the last 28 days

Time frame: 4 months

CPAP-adherence

CPAP-adherence defined as the % of patients with a CPAP-adherence \>4h/day, CPAP-adherence reported by the CPAP-software for the last 28 days.

Time frame: 12 months

CPAP-leaks

important leaks (l/min or % or min/days) reported by the CPAP-software for the last 28 days

Time frame: 4 months

CPAP-leaks

important leaks (l/min or % or min/days) reported by the CPAP-software for the last 28 days

Time frame: 12 months

Patient subjective sleepiness

reported by the patient using the Epworth Sleepiness Scale (0-24)

Time frame: 4 months

Patient subjective sleepiness

reported by the patient using the Epworth Sleepiness Scale (0-24)

Time frame: 12 months

Patient subjective depression

reported by the patient using the Pichot Depression Scale (0-13)

Time frame: 12 months

Central Contacts

Dany Jaffuel, MD, PhD

CONTACT

+33467314840 dany.jaffuel@wanadoo.fr

Arnaud Prigent, MD

CONTACT

a.prigent@stv-stlaurent.fr

Data from ClinicalTrials.gov

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