Autoset for Her for Her and Him

Autoset for Her for Her and Him - AfH

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00012568

Enrollment

Registered

2017-06-13

Start date

2016-07-06

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 G47.3

Interventions

Group 1: Women with a diagnosis of severe sleep apnoea (OSA) in which an OSA therapy by automated CPAP (APAP) is initiated. In a randomized sequence the Autoset for Her therapy device is operating in

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: severe sleep apnoea, Initiation of CPAP therapy

Exclusion criteria

Exclusion criteria: predominant central sleep apnoea, relevant heart/lung disease NYHA class I/II, neurological diseases, periodic limb movement disorder (PLMD) or elevated number of periodic limb movements during sleep

Design outcomes

Primary

Measure	Time frame
Treatment of flow limitations: comparison of the mean airflow per breathing cycle for each sleep Phase (N1, N2, N3, REM) in dependence on APAP mode (first/second half of the night)	—

Secondary

Measure	Time frame
treatment of apnoea/hypopnoea: Comparison of apnoea index (AI), hypopnoea index (HI) and apnoea/hypopnoea index (AHI) during the total sleep time (TST) in dependence on APAP mode (first/second half of the night)	—

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