The TELEAP1 CPAP-telemonitoring Study

NCT04897646 | Unknown

• 1 other identifier: RECHMPL21_0082
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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..

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep apnea; Continuous Positive Airway Pressure,; Telemedicine; COVID 19; observance; leaks; apnea hypopnea index.

Outcome Measures

Primary Outcomes (1)

• CPAP-complianceversus corresponding 2019 weeks (h/days)

  CPAP-compliance (hour/day) reported by the CPAP-software for the last 28 days

  4 months

Secondary Outcomes (18)

• AHIflow

  4 months

• CPAP-adherence

  12 months

• CPAP-leaks

  4 months

• CPAP-leaks

  12 months

• Patient subjective sleepiness

  4 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Previous CPAP-treatment
• Pregnancy
• Inability to understand the nature and aims of the study or to communicate with the investigator
• No affiliation with the French social security regime
• Loss of personal capacity resulting in state protection
• Deprivation of liberty by judicial or administrative decision

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• ADENE, Montpellier: collaborator
• AGIR à dom, Meylan: collaborator
• ASTEN sante, Pays de la Loire: collaborator
• ELIA medical, Cesson-Sévigné: collaborator

Study Sites (1)

Uhmontpellier

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; COVID-19

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Study Officials

• Dany Jaffuel, MD,PhD

  Montpellier University Hospitals

  PRINCIPAL INVESTIGATOR

• Fréderic Gagnadoux

  University Hospital, Angers

  STUDY DIRECTOR

• Arnaud Prigent

  Polyclinique Saint Laurent - Rennes

  PRINCIPAL INVESTIGATOR

• Renaud Tamisier, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dany Jaffuel, MD, PhD

CONTACT

+33467314840; dany.jaffuel@wanadoo.fr

Arnaud Prigent, MD

CONTACT

a.prigent@stv-stlaurent.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: May 1, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2023
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)