NCT03043716

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 14,147 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2017-08-01
• Primary completion: 2025-09-30
• Completion: 2025-12-31
• First posted: 2017-02-06
• Last updated: 2024-05-28

Locations

6 sites across 1 country: Germany