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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; Central Sleep Apnea; Mixed Sleep Apnea
• Intervention / Treatment: Other: PAP therapy with telemonitoring

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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Oliver Munt, Dr; Phone Number: +49(0)1629056360; Email: oliver.munt@resmed.de

Study Locations

• Germany
  • Berlin, Germany, 12683
    • Recruiting
    • Zentrum für Schlafmedizin Dr. Warmuth
    • Contact: Ralf Warmuth, Dr; Phone Number: 03023254320; Email: info@schlafdoktor.de
  • Baden-Württemberg
    • Blaubeuren, Baden-Württemberg, Germany, 89143
      • Recruiting
      • Schlaf- und Beatmungszentrum Blaubeuren
      • Contact: Holger Wöhrle
  • Bavaria
    • Fürth, Bavaria, Germany, 90762
      • Recruiting
      • Ambulante Schlafmedizin Herold/Kaa
      • Contact: Jürgen Herold, Dr; Phone Number: 09171825880
    • Nürnberg, Bavaria, Germany, 90419
      • Recruiting
      • Klinikum Nürnberg-Med Klinik 3
      • Contact: Dora Trichè, Dr; Phone Number: 09113980
  • Nordrhein-Westfalen
    • Dusseldorf, Nordrhein-Westfalen, Germany, 40235
      • Recruiting
      • Klinik für Schlafmedizin Düsseldorf Grand Arc
      • Contact: Hartmut Grüger, Dr
  • Northrhine-Westphalia
    • Essen, Northrhine-Westphalia, Germany, 45239
      • Recruiting
      • Ruhrlandklinik Essen
      • Contact: Christoph Schöbel, Prof; Phone Number: 020143301
      • Contact: Sarah Terjung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adult individuals with an indication for a therapy with positive airway pressure. Sleep breathing disorders can be obstructive (obstructive sleep apnea, OSA) or central (CSA) ranging from mild forms (apnoea-hypopnoea-index ˃ 5 and ˂ 15) over moderate (AHI ˃15 and ˂30) or severe (AHI ˃ 30).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: ResMed
• Collaborators: RWTH Aachen University
• Investigators: Principal Investigator: Hartmut Grüger, Dr, Grand Arc Düsseldorf

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimated): February 6, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Sleep Apnea, Central
• Other Study ID Numbers: TelePAP_Protokoll_V02_17072017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No