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

Obstructive Sleep Apnea Clinical Trial

— TelePAP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03043716
• Other study ID #: TelePAP_Protokoll_V02_17072017
• Status: Active, not recruiting
• Start date: August 1, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14147
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Germany	Zentrum für Schlafmedizin Dr. Warmuth	Berlin
Germany	Schlaf- und Beatmungszentrum Blaubeuren	Blaubeuren	Baden-Württemberg
Germany	Klinik für Schlafmedizin Düsseldorf Grand Arc	Dusseldorf	Nordrhein-Westfalen
Germany	Ruhrlandklinik Essen	Essen	Northrhine-Westphalia
Germany	Ambulante Schlafmedizin Herold/Kaa	Fürth	Bavaria
Germany	Klinikum Nürnberg-Med Klinik 3	Nürnberg	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
ResMed	RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usage Patterns of PAP therapy with telemonitoring, assessed by data continuously recorded by the device and transferred via telemonitoring	Usage Patterns are hours/night and nights/month that therapy has been used. Telemonitoring enables the physician to remotely supervise device usage. Usage will be assessed through data recordings of the device: Days of usage >3hours; Days of usage <3 hours; total recorded days; mean daily usage (minutes); total usage hours (h)	24 months
Secondary	Sleep disorders, assessed by personally questioning the Patient at baseline and at 24 months follow-up	Sleep disorders are snoring, insomnia, hypersomnia, depression, restless legs syndrome as assessed by anamnesis.	24 months
Secondary	Therapy efficacy, assessed through changes in AHI and HI comparing baseline with 24 months follow-up	Efficacy is measured through changes in Apnea-Hypopnea-Index AHI (numbers of apneas - reduction of airflow by >90% for at least 10 seconds - and hypopneas - reduction of airflow by >30% for at least 10 seconds with a 4% decrease of Oxygen Saturation - divided by hours of sleep), AI - apnea index (apneas per hour), HI hypopnea index (hypopneas per hour).	24 months
Secondary	Quality of Life, assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) comparing the score at baseline with the 24 months follow-up	The Functional Outcomes of Sleep Questionnaire had been developed to comprehensively capture the impact of sleeping disorders in relevant daily activities as for instance general activity, vigilance, intimacy, fitness and social life.	24 months
Secondary	Factors leading to therapy Termination, assessed by personally questioning a Patient or Consulting a physician at time of follow-up	Possible causes for therapy Termination are assessed: Lost-to-follow-up, no interest in therapy, changed physician, no therapy benefits, Hospital stay, death	24 months