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

Obstructive Sleep Apnea Clinical Trial

Official title: Long-term Observation of Adherence and Efficacy of Patients With a Positive Airway Pressure (PAP) Therapy With Use of Telemonitoring

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apnea
• Mixed Sleep Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Central
• Sleep Apnea, Obstructive

• NCT number: NCT03043716
• Study type: Observational [Patient Registry]
• Source: ResMed
• Contact: Oliver Munt, Dr
• Phone: +49(0)1629056360
• Email: oliver.munt@resmed.de
• Status: Recruiting
• Start date: August 1, 2017
• Completion date: January 31, 2024