Obstructive Sleep Apnea
Conditions
Keywords
Obstructive Sleep apnea, Continuous Positive Airway Pressure,, Telemedicine, COVID 19, observance, leaks, apnea hypopnea index.
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.
Interventions
OTHERSFRMS/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.
Sponsors
ADENE, Montpellier
AGIR à dom, Meylan
ASTEN sante, Pays de la Loire
ELIA medical, Cesson-Sévigné
University Hospital, Montpellier
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPAP-complianceversus corresponding 2019 weeks (h/days) | 4 months | CPAP-compliance (hour/day) reported by the CPAP-software for the last 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| CPAP-leaks | 4 months | important leaks (l/min or % or min/days) reported by the CPAP-software for the last 28 days |
| Patient subjective sleepiness | 4 months | reported by the patient using the Epworth Sleepiness Scale (0-24) |
| Patient subjective depression | 12 months | reported by the patient using the Pichot Depression Scale (0-13) |
| Unplanned patient phone call | Day 0 to 360 | unplanned patient phone call with the technician regardless of the reason |
| Patient subjective insomnia | 4 months | reported by the patient using the Insomnia Severity Scale (0-28) |
| CPAP-compliance | 12 months | CPAP-compliance (hour/day) reported by the CPAP-software for the last 28 days |
| AHIflow | 4 months | AHIflow (events/hour) reported by the CPAP-software for the last 28 days |
| 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 |
| 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) |
| Interface-type change | Day 0 to 360 | description of the interface-type change (nasal, nasal pillows, oronasal) regardless of the reason |
| Pressure settings modification | Day 0 to 360 | Change in the CPAP-pressure settings regardless of the reason |
| CPAP-mode modification | Day 0 to 360 | Change in the CPAP mode (constant or auto-CPAP) regardless of the reason |
| Unplanned technician phone call | Day 0 to 360 | unplanned technician phone call with the patient regardless of the reason |
Countries
France
Contacts
Primary ContactDany Jaffuel, MD, PhD
Backup ContactArnaud Prigent, MD
Outcome results
None listed