Validity of device-internal AHI detection during OSA therapy with regard to its application in telemonitoring

Validity of device-internal AHI detection during OSA therapy with regard to its application in telemonitoring - Tele-AHI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00018351

Enrollment

100

Registered

2020-02-12

Start date

2019-04-09

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G47.3

Interventions

Group 1: Comparison of simultaneously measured values of the therapy device with those from the external polygraphic or polysomnographic devices, especially comparison of the number and quality of det

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Polysomnographic or polygraphic control of a device based sleep apnoea therapy with devices of the types AirSense 10 Autoset, AirSense 10 Elite, AirSense 10 Autoset for Her, SOMNObalance, SOMNOsoft 2 oder prismaSMART

Exclusion criteria

Exclusion criteria: Mask leakage >25L/min, therapy duration during recording time 10% of therapy duration

Design outcomes

Primary

Measure	Time frame
The aim of the study is to determine the accuracy of accordance of the device-internal AHI registration with those values detected by standard poly-/somno-/graphic measurement. This accuracy will be expressed as regression analysis and graphically documented by inserting the respective regression line into the cloud of resulting measurement data. The possible deviation in both data sets will be characterized as systematic or dispersed.	—

Measure

Time frame

The aim of the study is to determine the accuracy of accordance of the device-internal AHI registration with those values detected by standard poly-/somno-/graphic measurement. This accuracy will be expressed as regression analysis and graphically documented by inserting the respective regression line into the cloud of resulting measurement data. The possible deviation in both data sets will be characterized as systematic or dispersed.

—

Secondary

Measure	Time frame
The accuracy of accordance of the device-internal AHI registration with those values detected by standard poly-/somno-/graphic measurement will be analysed separately for each class of respiratory events (obstructive/central/mixed apnoea, hypopnoea, RERAs) to determine homogeneity in the event detection.	—

Countries

Germany

Contacts

Public ContactJens Kerl

Fachkrankenhaus Kloster Grafschaft GmbH

j.kerl@fkkg.de02972-7911703

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026