Abstract
STUDY OBJECTIVES: The current gold standard for assessment of obstructive sleep apnea is the in-laboratory polysomnography. This approach has high costs and inconveniences the patient, whereas alternative ambulatory systems are limited by reduced diagnostic abilities (type 4 monitors, 1 or 2 channels) or extensive setup (type 3 monitors, at least 4 channels). The current study therefore aims to validate a simplified automated type 4 monitoring system using tracheal body sound and movement data. METHODS: Data from 60 subjects were recorded at the University Hospital Ulm. All subjects have been regular patients referred to the sleep center with suspicion of sleep-related breathing disorders. Four recordings were excluded because of faulty data. The study was of prospective design. Subjects underwent a full-night screening using diagnostic in-laboratory polysomnography and the new monitoring system concurrently. The apnea-hypopnea index (AHI) was scored blindly by a medical technician using in-laboratory polysomnography (AHI(PSG)). A unique algorithm was developed to estimate the apneahypopnea index (AHI(est)) using the new sleep monitor. RESULTS: AHI(est) strongly correlates with AHI(PSG) (r(2) = .9871). A mean ± 1.96 standard deviation difference between AHI(est) and AHI(PSG) of 1.2 ± 5.14 was achieved. In terms of classifying subjects into groups of mild, moderate, and severe sleep apnea, the evaluated new sleep monitor shows a strong correlation with the results obtained by polysomnography (Cohen kappa > 0.81). These results outperform previously introduced similar approaches. CONCLUSIONS: The proposed sleep monitor accurately estimates AHI and diagnoses sleep apnea and its severity. This minimalistic approach may address the need for a simple yet reliable diagnosis of sleep apnea in an ambulatory setting. CLINICAL TRIAL REGISTRATION: Trial name: Validation of a new method for ambulant diagnosis of sleep related breathing disorders using body sound; URL: https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00011195; Identifier: DRKS00011195.