About this trial
This prospective study aims to compare automated polysomnographic scoring with manual scoring in adult patients with Obstructive Sleep Apnea (OSA). The main objective is to evaluate the accuracy, reliability, and time efficiency of automated scoring algorithms compared to standard manual scoring performed by expert sleep specialists
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years.
Clinical suspicion of OSA based on history, physical examination, and a positive screening questionnaire (e.g., STOP-BANG ≥ 3).
Ability to provide written informed consent.
Disqualifiers
Age ≤ 18 years.
Inability to give informed consent (e.g., severe cognitive impairment, language barrier).
Contraindications to PSG (e.g., severe skin conditions preventing electrode placement).
Current use of therapies that could alter sleep architecture (e.g., highdose benzodiazepines, opioids) unless a wash-out period is observed.
Trial population
Patients referred to the sleep unit with suspected OSA who are scheduled for an overnight diagnostic PSG.
Trial design
Cohort
Prospective
Treatments tested in this trial
Polysomnographic Scoring (Automated vs. Manual)
Diagnostic testComparison between automated scoring software and standard manual scoring by expert specialists for sleep study records.
Treatment groups
Trial outcomes
Primary outcomes
Apnea-Hypopnea Index (AHI) Agreement
Comparison of the Apnea-Hypopnea Index (AHI) values obtained from automated polysomnographic scoring against those obtained from manual scoring.
Sponsors and contacts
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