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Validation of a new method for ambulant diagnosis of sleep related breathing disorders using body sound.

Validation of a new method for ambulant diagnosis of sleep related breathing disorders using body sound.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00011195
Enrollment
60
Registered
2016-10-18
Start date
2016-11-02
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: During their regular diagnosis night in the sleep laboratory, participating subjects carry the new sleep monitor parallel to the polysomnography. The sleep monitor consists of two components.

Sponsors

Universitätsklinikum Ulm
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: • Signed consent • Suspected sleep-related breathing disorder

Exclusion criteria

Exclusion criteria: • known allergies or intolerances with patches • serious illnesses or diseases that affect the participation of the subjects in the study or make them impossible • Lack of willingness to participate in the study

Design outcomes

Primary

MeasureTime frame
The aim of this study is to verify if the new sleep monitor (body sound) is equivalent to polysomnography in the diagnosis of sleep-related respiratory disorders.

Secondary

MeasureTime frame
The secondary aim of this study is to verify if the new sleep monitor can be used reliably and without any complications. Another secondary aim of this study is to examine if there are other correlations between the data of the new sleep monitor (e.g. heart sounds and respiratory sounds) and PSG (e.g. ECG and respiratory flow).

Countries

Germany

Contacts

Public ContactCornelia Kropf-Sanchen

Universitätsklinikum Ulm

Cornelia.Kropf@uniklinik-ulm.de0731 50-45067

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 8, 2026