Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ADENE, Montpellier | UNKNOWN |
| AGIR Ã dom, Meylan | UNKNOWN |
| ASTEN sante, Pays de la Loire | UNKNOWN |
| ELIA medical, Cesson-Sévigné |
Not provided
Not provided
Not provided
Not provided
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..
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SFRMS/SPLF CPAP-telemonitoring diagnosis/therapeutic algorithm. | Other | 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. |
| 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 |
| 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. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Patients included in the study are newly CPAP-treated with a diagnosis of obstructive sleep apnea.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dany Jaffuel, MD, PhD | Contact | +33467314840 | dany.jaffuel@wanadoo.fr | |
| Arnaud Prigent, MD | Contact | a.prigent@stv-stlaurent.fr |
| Name | Affiliation | Role |
|---|---|---|
| Dany Jaffuel, MD,PhD | Montpellier University Hospitals | Principal Investigator |
| Fréderic Gagnadoux | University Hospital, Angers | Study Director |
| Arnaud Prigent |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uhmontpellier | Recruiting | Montpellier | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| UNKNOWN |
Not provided
Not provided
Not provided
| 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 |
| Polyclinique Saint Laurent - Rennes |
| Principal Investigator |
| Renaud Tamisier, MD, PhD | University Hospital, Grenoble | Principal Investigator |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |