Computer-aided diagnostics of sleep-related arousals on the basis of pulse wave analyses

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00033641

Enrollment

200

Registered

2024-02-26

Start date

2021-01-25

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

Sleep apnea, Periodic Limb Movement Disorder (PLMD), Restless Legs Syndrome (RLS), Insomnia, Parasomnias, Bruxism

Interventions

Group 1: Men and women aged 18 and older who are referred for polysomnography to the sleep laboratory of the Klinik für Kardiologie, Angiologie u. Pneumologie of the medical clinic in Esslingen am Nec

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Referral for a polysomnographic diagnostic examination

Exclusion criteria

Exclusion criteria: Examinations in which therapeutic methods in the form of positive pressure therapies are used are excluded.

Design outcomes

Primary

Measure	Time frame
1. The efficiency of arousal diagnostics is to be improved. Thus, the time required compared to the current effort for manual evaluation of the measurement data from the entire night is to be reduced. 2. The quality of arousal diagnostics, measured by precision and recall metrics, should reach a level that is comparable to the best medical expert involved in the study. 3. The technical complexity, measured by the number of required EEG, EMG, and EOG channels, is to be reduced. Regarding the 2nd primary endpoint, the performance of AI models trained on the collected data will be continuously assessed from the start of data collection. If it becomes apparent that model accuracies can no longer be increased by additional patient datasets, no further patients will be included in the study. All primary endpoints will be evaluated in a user study by no later than four years after the last study participant was enrolled.	—

Measure

Time frame

1. The efficiency of arousal diagnostics is to be improved. Thus, the time required compared to the current effort for manual evaluation of the measurement data from the entire night is to be reduced. 2. The quality of arousal diagnostics, measured by precision and recall metrics, should reach a level that is comparable to the best medical expert involved in the study. 3. The technical complexity, measured by the number of required EEG, EMG, and EOG channels, is to be reduced. Regarding the 2nd primary endpoint, the performance of AI models trained on the collected data will be continuously assessed from the start of data collection. If it becomes apparent that model accuracies can no longer be increased by additional patient datasets, no further patients will be included in the study. All primary endpoints will be evaluated in a user study by no later than four years after the last study participant was enrolled.

—

Secondary

Measure	Time frame
1. The system outputs of the decision-support system should be transparent and understandable for the users. 2. The clinical relevance of arousals, measured by the medical diagnosis, the Epworth Sleepiness Scale (ESS), and the Pittsburgh Sleep Quality Index (PSQI) value of the patient, should be investigated. 3. Rules and markers for the system results should be identified and aligned with the current medical knowledge and scoring rules.	—

Measure

Time frame

1. The system outputs of the decision-support system should be transparent and understandable for the users. 2. The clinical relevance of arousals, measured by the medical diagnosis, the Epworth Sleepiness Scale (ESS), and the Pittsburgh Sleep Quality Index (PSQI) value of the patient, should be investigated. 3. Rules and markers for the system results should be identified and aligned with the current medical knowledge and scoring rules.

—

Countries

Germany

Contacts

Public ContactStefan Kraft

STZ Softwaretechnik GmbH

stefan.kraft@stz-softwaretechnik.de+49 711 400 48-100

Outcome results

None listed

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