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

NCT03043716 | Active Not Recruiting

• 1 other identifier: TelePAP_Protokoll_V02_17072017
• Study Type: observational
• Target: 14,147
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Obstructive Sleep Apnea; Central Sleep Apnea; Mixed Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sleep disorders, assessed by personally questioning the Patient at baseline and at 24 months follow-up

  24 months

• Therapy efficacy, assessed through changes in AHI and HI comparing baseline with 24 months follow-up

  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

  24 months

• Factors leading to therapy Termination, assessed by personally questioning a Patient or Consulting a physician at time of follow-up

  24 months

Interventions

PAP therapy with telemonitoring OTHER

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• \- Pregnant and breastfeeding persons

Sponsors & Collaborators

• ResMed: lead
• RWTH Aachen University: collaborator

Study Sites (6)

Schlaf- und Beatmungszentrum Blaubeuren

Blaubeuren Abbey, Baden-Wurttemberg, 89143, Germany

Location

Ambulante Schlafmedizin Herold/Kaa

Fürth, Bavaria, 90762, Germany

Location

Klinikum Nürnberg-Med Klinik 3

Nuremberg, Bavaria, 90419, Germany

Location

Klinik für Schlafmedizin Düsseldorf Grand Arc

Düsseldorf, North Rhine-Westphalia, 40235, Germany

Location

Ruhrlandklinik Essen

Essen, North Rhine-Westphalia, 45239, Germany

Location

Zentrum für Schlafmedizin Dr. Warmuth

Berlin, 12683, Germany

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea, Central; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Hartmut Grüger, Dr

  Grand Arc Düsseldorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 6, 2017
• Study Start: August 1, 2017
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

DE (6)