The TELEAP1 CPAP-telemonitoring Study

Study Overview
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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.

Official Title
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Evaluation of a CPAP Telemonitoring Algorithm for Newly Treated Patients: the TELEAP1 Multicenter Cohort Pilot Study

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Other: SFRMS/SPLF CPAP-telemonitoring diagnosis/therapeutic algorithm.


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP-complianceversus corresponding 2019 weeks (h/days) | CPAP-compliance (hour/day) reported by the CPAP-software for the last 28 days | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AHIflow | AHIflow (events/hour) reported by the CPAP-software for the last 28 days | 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. | 12 months | 
| CPAP-leaks | important leaks (l/min or % or min/days) reported by the CPAP-software for the last 28 days | 4 months | 
| CPAP-leaks | important leaks (l/min or % or min/days) reported by the CPAP-software for the last 28 days | 12 months | 
| Patient subjective sleepiness | reported by the patient using the Epworth Sleepiness Scale (0-24) | 4 months | 
| Patient subjective sleepiness | reported by the patient using the Epworth Sleepiness Scale (0-24) | 12 months | 
| Patient subjective depression | reported by the patient using the Pichot Depression Scale (0-13) | 12 months | 
| Patient subjective insomnia | reported by the patient using the Insomnia Severity Scale (0-28) | 4 months | 
| Patient subjective insomnia | reported by the patient using the Insomnia Severity Scale (0-28) | 12 months | 
| CPAP-compliance | CPAP-compliance (hour/day) reported by the CPAP-software for the last 28 days | 12 months | 
| Unplanned patient phone call | unplanned patient phone call with the technician regardless of the reason | Day 0 to 360 | 
| Unplanned technician phone call | unplanned technician phone call with the patient regardless of the reason | Day 0 to 360 | 
| Unplanned patient visit | unplanned patient visit to the care provider regardless of the reason | Day 0 to 360 | 
| Unplanned technician visit | unplanned technician visit to the patient regardless of the reason | Day 0 to 360 | 
| CPAP telemonitoring alarm | number and type (cpap observance < 4h for the last 7 days, and or IAHflow >10/h for the last 7 days, and or important leaks for the last 7 days) | Day 0 to 360 | 
| Interface-type change | description of the interface-type change (nasal, nasal pillows, oronasal) regardless of the reason | Day 0 to 360 | 
| Pressure settings modification | Change in the CPAP-pressure settings regardless of the reason | Day 0 to 360 | 
| CPAP-mode modification | Change in the CPAP mode (constant or auto-CPAP) regardless of the reason | Day 0 to 360 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep apnea, Continuous Positive Airway Pressure,, Telemedicine, COVID 19, observance, leaks, apnea hypopnea index.