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May 10, 2026SLEEP0 citations

Phase 3 Trial of Auditory Neuromodulation in Insomnia Using BELL-001

0433 An Auditory Neuromodulation-Based Prescription Digital Therapeutic for Insomnia Disorder: Phase 3 Trial Protocol (SERENE)

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Authors

KKKyunghee KimJPJonghwa ParkHKH. S. Kim

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Overview

Randomized trial investigates efficacy of BELL-001 for insomnia, suggesting a novel therapeutic option.

Key Points

  • This trial aims to evaluate the efficacy and safety of BELL-001, a digital therapeutic for insomnia, in adults.
  • Multicenter, prospective, randomized, double-blind, sham-controlled superiority trial.
  • 114 participants aged 19-75 with insomnia diagnosis and ISI score ≥15 will be enrolled.
  • Primary endpoint is change in ISI score from baseline to 4 weeks.
  • Trial has received approval from Korean Ministry of Food and Drug Safety.
  • Evaluates primary endpoint of ISI score reduction at 4 weeks.
  • Assesses treatment-emergent adverse events for safety analysis.
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Cite This Study

Kim et al. (2026) studied this question.

synapsesocial.com/papers/6a0021e6c8f74e3340f9ccc1https://doi.org/10.1093/sleep/zsag091.0433
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