The TELEAP1 CPAP-telemonitoring Study

Obstructive Sleep Apnea Clinical Trial

— TELEAP1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04897646
• Other study ID #: RECHMPL21_0082
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: December 15, 2023

Study information

• Verified date: May 2021
• Source: University Hospital, Montpellier
• Contact: Dany Jaffuel, MD, PhD
• Phone: +33467314840
• Email: dany.jaffuel[@]wanadoo.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Montpellier	ADENE, Montpellier, AGIR à dom, Meylan, ASTEN sante, Pays de la Loire, ELIA medical, Cesson-Sévigné

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPAP-complianceversus corresponding 2019 weeks (h/days)	CPAP-compliance (hour/day) reported by the CPAP-software for the last 28 days	4 months
Secondary	AHIflow	AHIflow (events/hour) reported by the CPAP-software for the last 28 days	4 months
Secondary	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
Secondary	CPAP-leaks	important leaks (l/min or % or min/days) reported by the CPAP-software for the last 28 days	4 months
Secondary	CPAP-leaks	important leaks (l/min or % or min/days) reported by the CPAP-software for the last 28 days	12 months
Secondary	Patient subjective sleepiness	reported by the patient using the Epworth Sleepiness Scale (0-24)	4 months
Secondary	Patient subjective sleepiness	reported by the patient using the Epworth Sleepiness Scale (0-24)	12 months
Secondary	Patient subjective depression	reported by the patient using the Pichot Depression Scale (0-13)	12 months
Secondary	Patient subjective insomnia	reported by the patient using the Insomnia Severity Scale (0-28)	4 months
Secondary	Patient subjective insomnia	reported by the patient using the Insomnia Severity Scale (0-28)	12 months
Secondary	CPAP-compliance	CPAP-compliance (hour/day) reported by the CPAP-software for the last 28 days	12 months
Secondary	Unplanned patient phone call	unplanned patient phone call with the technician regardless of the reason	Day 0 to 360
Secondary	Unplanned technician phone call	unplanned technician phone call with the patient regardless of the reason	Day 0 to 360
Secondary	Unplanned patient visit	unplanned patient visit to the care provider regardless of the reason	Day 0 to 360
Secondary	Unplanned technician visit	unplanned technician visit to the patient regardless of the reason	Day 0 to 360
Secondary	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
Secondary	Interface-type change	description of the interface-type change (nasal, nasal pillows, oronasal) regardless of the reason	Day 0 to 360
Secondary	Pressure settings modification	Change in the CPAP-pressure settings regardless of the reason	Day 0 to 360
Secondary	CPAP-mode modification	Change in the CPAP mode (constant or auto-CPAP) regardless of the reason	Day 0 to 360