Computer-aided diagnostics of sleep-related arousals on the basis of pulse wave analyses
- Conditions
- Sleep apnea, Periodic Limb Movement Disorder (PLMD), Restless Legs Syndrome (RLS), Insomnia, Parasomnias, Bruxism
- Registration Number
- DRKS00033641
- Lead Sponsor
- Klinikum Esslingen, Klinik für Kardiologie, Pneumologie und Angilologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 125
Inclusion Criteria
Referral for a polysomnographic diagnostic examination
Exclusion Criteria
Examinations in which therapeutic methods in the form of positive pressure therapies are used are excluded.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>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.<br>3. The technical complexity, measured by the number of required EEG, EMG, and EOG channels, is to be reduced.<br><br>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.<br>All primary endpoints will be evaluated in a user study by no later than four years after the last study participant was enrolled.
- Secondary Outcome Measures
Name Time Method 1. The system outputs of the decision-support system should be transparent and understandable for the users.<br>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.<br>3. Rules and markers for the system results should be identified and aligned with the current medical knowledge and scoring rules.