Hong-Min Lin, Ming-Chung Ho, Yan-Lin Zhong, Chih-Hung Tsai, Wan-Ting Hsieh
BDAS demonstrated feasibility and acceptability in a healthcare professional setting. The observed within-participant improvements in insomnia severity and exploratory EEG parameters provide a preliminary signal and effect size estimates to inform future randomized controlled trials. Because the design was single-arm and uncontrolled, these within-participant changes cannot be attributed to BDAS specifically.
BACKGROUND: Insomnia and sleep disturbances are highly prevalent among healthcare professionals and pose risks to patient safety. Brain Dynamic Audio Stimulation (BDAS) is a non-invasive, open-loop auditory intervention intended to facilitate sleep initiation. This single-arm pilot feasibility study examined the feasibility and preliminary signal of a 14-day BDAS intervention in healthcare professionals with subjective sleep disturbances.
METHODS: Of 30 healthcare professionals assessed for eligibility, 15 were enrolled. Participants received one 30-min BDAS session nightly for 14 consecutive days. Insomnia severity was assessed using the Insomnia Severity Index (ISI) at baseline and Day 14. Short-duration EEG recordings (30 min, time-locked to BDAS, focused on sleep initiation) were obtained at both time points. Pre-post changes were analyzed using paired-sample tests; EEG outcomes were considered exploratory.
RESULTS: All 15 participants completed the intervention (100% retention; no adverse events). Mean ISI scores decreased from 10.00 (SD 5.55) to 4.27 (SD 2.69) (mean change -5.73; 95% CI - 8.15 to -3.32; Cohen's dz = 1.31; p < 0.001). Exploratory EEG analyses showed reductions in sleep onset latency (828 s to 480 s; dz = 0.89; p = 0.004) and increases in 30-min sleep efficiency (34.8 to 46.8%; dz = 0.57; p = 0.045). All predefined feasibility progression criteria were met.
CONCLUSION: BDAS demonstrated feasibility and acceptability in a healthcare professional setting. The observed within-participant improvements in insomnia severity and exploratory EEG parameters provide a preliminary signal and effect size estimates to inform future randomized controlled trials. Because the design was single-arm and uncontrolled, these within-participant changes cannot be attributed to BDAS specifically.