The TELEAP1 CPAP-telemonitoring Study (TELEAP1)

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

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..

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: SFRMS/SPLF CPAP-telemonitoring diagnosis/therapeutic algorithm.

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Dany Jaffuel, MD, PhD; Phone Number: +33467314840; Email: dany.jaffuel@wanadoo.fr
• Study Contact Backup: Name: Arnaud Prigent, MD; Email: a.prigent@stv-stlaurent.fr

Study Locations

• France
  • Montpellier, France
    • Recruiting
    • Uhmontpellier
    • Contact: Dany Jaffuel, MD, PhD; Phone Number: 33 4 67 33 63 03; Email: dany.jaffuel@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients included in the study are newly CPAP-treated with a diagnosis of obstructive sleep apnea.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: ADENE, Montpellier; AGIR à dom, Meylan; ASTEN sante, Pays de la Loire; ELIA medical, Cesson-Sévigné
• Investigators: Principal Investigator: Dany Jaffuel, MD,PhD, Montpellier University Hospitals; Study Director: Fréderic Gagnadoux, University Hospital, Angers; Principal Investigator: Arnaud Prigent, Polyclinique Saint Laurent - Rennes

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): December 15, 2021
• Study Completion (Anticipated): December 15, 2023

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Telemedicine; COVID 19; Obstructive Sleep apnea; observance; leaks; Continuous Positive Airway Pressure,; apnea hypopnea index.
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: RECHMPL21_0082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No