Long-term Observation of PAP-therapy With Telemonitoring: Telemedicine Registry TelePAP

NCT ID: NCT03043716

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 14147 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2025-12-31

Brief Summary

Telemonitoring for Positive Airway Pressure (PAP) therapy might help to establish and maintain long-term therapy adherence and thus support the beneficial effects of PAP therapy on long-term outcomes.

Detailed Description

Airway obstructions, airflow resistance by partial occlusion of the airways or central sleep-breathing disorders, where the respiratory effort is reduced or stops, cause a reduction in airflow and lead to arousals from sleep and disturbances in gas exchange during sleep. The negative consequences manifest in increases of blood pressure, higher workload for the heart and daytime sleepiness. PAP (positive airway pressure) treats sleep-related breathing disorders. It applies pressure to nose and mouth to keep the airway from collapsing and provides pressure support to assist the respiratory muscles. The efficacy of the therapy is measured with apnoea- and hypopnoea-indices that count the total number of apnoeic events at night. To ensure an efficacious and efficient therapy, pressures have to be adjusted correctly and the patient needs to use PAP regularly.

Telemonitoring is information and communication technology to exchange sleep data and to provide clinical guidance over distances. There is no defined spectrum of technology. It can comprise phone calls, video support or interaction programs via the internet. Some studies point to advantages of telemonitoring in keeping compliance upright, increase usage hours and some also point to economic advantages. However, we do not have conclusive data from large trials with telemonitoring on the long-term that would show conclusive effects, be it from the side of a patient or from a cost and labour perspective of providers or the healthcare sector. Still, there are uncertainties regarding data safety, reimbursement or connectivity of different systems.

No long-term data of PAP therapy under telemonitoring and its effect on compliance and therapy outcomes is available by now.

Conditions

Obstructive Sleep Apnea; Central Sleep Apnea; Mixed Sleep Apnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

PAP therapy with telemonitoring

Patients will receive a prescription for PAP therapy in the course of their clinical Routine pathway and afterwards be asked to enrol in the registry. The will be asked if they are willing to use telemonitoring technology.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients older than 18 years
• New indication for a prescription of a Telemonitoring (AirViewTM)-capable ResMed PAP-device
• Consent to use the telemonitoring System AirViewTM (ResMed GmbH & Co KG)
• Signed Informed Consent

Exclusion Criteria

• Pregnant and breastfeeding persons

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: collaborator

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hartmut Grüger, Dr

Role: PRINCIPAL_INVESTIGATOR

Grand Arc Düsseldorf

Locations

Schlaf- und Beatmungszentrum Blaubeuren

Blaubeuren Abbey, Baden-Wurttemberg, Germany

Ambulante Schlafmedizin Herold/Kaa

Fürth, Bavaria, Germany

Klinikum Nürnberg-Med Klinik 3

Nuremberg, Bavaria, Germany

Klinik für Schlafmedizin Düsseldorf Grand Arc

Düsseldorf, North Rhine-Westphalia, Germany

Ruhrlandklinik Essen

Essen, North Rhine-Westphalia, Germany

Zentrum für Schlafmedizin Dr. Warmuth

Berlin, , Germany

Countries

Germany

Other Identifiers

TelePAP_Protokoll_V02_17072017

Identifier Type: -

Identifier Source: org_study_id