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

  • STATUS
    Recruiting
  • End date
    Sep 26, 2023
  • participants needed
    10000
  • sponsor
    ResMed
Updated on 26 April 2021
Investigator
Oliver Munt, Dr
Primary Contact
Schlaf- und Beatmungszentrum Blaubeuren (0.9 mi away) Contact
+9 other location

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.

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.

Details
Condition Sleep apnea, Obstructive sleep apnea, Primary sleep apnea of newborn, Complex Sleep Apnea, Sleep Apnea Syndromes, central sleep apnea, obstructive sleep apnoea, obstructive sleep apnea syndrome
Treatment PAP therapy with telemonitoring
Clinical Study IdentifierNCT03043716
SponsorResMed
Last Modified on26 April 2021

Eligibility

Yes No Not Sure

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
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