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Background <p>Insomnia affects 10–15% of adults worldwide, significantly impairing quality of life, cognitive function, and work productivity. Current treatments present fundamental trade-offs: cognitive behavioral therapy for insomnia (CBT-I) demonstrates sustained efficacy but requires a prolonged treatment period, specialized therapists, and high patient engagement, while pharmacotherapy provides rapid relief but carries risks of dependence and cognitive impairment that limit long-term use. Existing prescription digital therapeutics (PDTs) address CBT-I’s accessibility barriers but inherit its delayed therapeutic onset and adherence challenges. BELL-001 is an auditory neuromodulation-based PDT designed to induce autonomic downregulation through real-time biosignal-responsive acoustic feedback, targeting hyperarousal as a core pathophysiological feature of insomnia.</p> Methods <p>This is a multicenter, prospective, randomized, double-blind, sham-controlled, superiority trial designed to evaluate the efficacy and safety of BELL-001 in adults with insomnia. A minimum of 114 participants aged 19–75&#xa0;years diagnosed with insomnia according to ICD-10 criteria (F51.0 or G47.0) and with an Insomnia Severity Index (ISI) score ≥ 15 will be enrolled from six clinical sites in the Republic of Korea. Eligible participants will be randomly assigned in a 1:1 ratio to either the treatment group using BELL-001 or the control group using a sham device. The primary endpoint is the change in ISI score from baseline to 4&#xa0;weeks. Secondary endpoints include the response rate (ISI reduction ≥ 6 points), subjective sleep onset latency and wake after sleep onset from sleep diaries, and validated questionnaires assessing sleepiness, fatigue, depression, anxiety, quality of life, and work productivity. Treatment-emergent adverse events will be evaluated for safety analysis.</p> Discussion <p>The SERENE trial will evaluate whether an auditory neuromodulation-based PDT can provide clinically meaningful improvements. If efficacy and safety are demonstrated, this study may support the potential of neuromodulation-based digital therapeutics as an additional treatment option for patients with insomnia disorder.</p> Trial registration {4} <p>ClinicalTrials.gov (NCT07295431). Registered on 22 December 2025. <a href="https://clinicaltrials.gov/study/NCT07295431">https://clinicaltrials.gov/study/NCT07295431</a></p>

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Auditory neuromodulation-based prescription digital therapeutic for insomnia disorder: study protocol for a randomized controlled trial (SERENE)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月9日

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  • Kyunghee Kim,
  • Hyeonjoong Kim,
  • Hyeyun Kim,
  • Jung-Won Shin,
  • Jun-Sang Sunwoo,
  • Jung-Ick Byun,
  • Kyoung Jin Hwang,
  • Jiyeon Ha,
  • Mangyeong Lee,
  • Juhee Cho,
  • Jonghwa Jeonglok Park,
  • Ki-Young Jung

摘要

Background

Insomnia affects 10–15% of adults worldwide, significantly impairing quality of life, cognitive function, and work productivity. Current treatments present fundamental trade-offs: cognitive behavioral therapy for insomnia (CBT-I) demonstrates sustained efficacy but requires a prolonged treatment period, specialized therapists, and high patient engagement, while pharmacotherapy provides rapid relief but carries risks of dependence and cognitive impairment that limit long-term use. Existing prescription digital therapeutics (PDTs) address CBT-I’s accessibility barriers but inherit its delayed therapeutic onset and adherence challenges. BELL-001 is an auditory neuromodulation-based PDT designed to induce autonomic downregulation through real-time biosignal-responsive acoustic feedback, targeting hyperarousal as a core pathophysiological feature of insomnia.

Methods

This is a multicenter, prospective, randomized, double-blind, sham-controlled, superiority trial designed to evaluate the efficacy and safety of BELL-001 in adults with insomnia. A minimum of 114 participants aged 19–75 years diagnosed with insomnia according to ICD-10 criteria (F51.0 or G47.0) and with an Insomnia Severity Index (ISI) score ≥ 15 will be enrolled from six clinical sites in the Republic of Korea. Eligible participants will be randomly assigned in a 1:1 ratio to either the treatment group using BELL-001 or the control group using a sham device. The primary endpoint is the change in ISI score from baseline to 4 weeks. Secondary endpoints include the response rate (ISI reduction ≥ 6 points), subjective sleep onset latency and wake after sleep onset from sleep diaries, and validated questionnaires assessing sleepiness, fatigue, depression, anxiety, quality of life, and work productivity. Treatment-emergent adverse events will be evaluated for safety analysis.

Discussion

The SERENE trial will evaluate whether an auditory neuromodulation-based PDT can provide clinically meaningful improvements. If efficacy and safety are demonstrated, this study may support the potential of neuromodulation-based digital therapeutics as an additional treatment option for patients with insomnia disorder.

Trial registration {4}

ClinicalTrials.gov (NCT07295431). Registered on 22 December 2025. https://clinicaltrials.gov/study/NCT07295431