The TELEAP1 CPAP-telemonitoring Study

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT04897646
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Status Verified: 2021-05
• Study Start: 2021-05-01
• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-18
• Last Update Submitted: 2021-05-18
• Study First Posted: 2021-05-21
• Last Update Posted: 2021-05-21
• Primary Completion: 2021-12-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CPAP-complianceversus corresponding 2019 weeks (h/days)	4 months	CPAP-compliance (hour/day) reported by the CPAP-software for the last 28 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France