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Auditory neuromodulation-based PDT (BELL-001) reduces insomnia severity in adults with insomnia disorder

The SERENE trial is a multicenter, randomized, double-blind, sham-controlled superiority trial evaluating BELL-001, an auditory neuromodulation-based prescription digital therapeutic, in adults with insomnia. The primary endpoint is change in Insomnia Severity Index (ISI) score from baseline to 4 weeks, with a minimum of 114 participants enrolled. The study aims to determine if this biosignal-responsive acoustic feedback intervention can provide clinically meaningful improvements in insomnia.

Last updated: Jul 16, 2026•1 RCTs•📖 Read as article →

Evidence Score

Evidence Score42/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★☆
Confidencelow

Study Evidence

Study 1. Auditory neuromodulation-based prescription digital therapeutic for insomnia disorder: study protocol for a randomized controlled trial (SERENE).

observational

Kim K, Kim H, Kim H, Shin JW, Sunwoo JS, Byun JI, Hwang KJ, Ha J, Lee M, Cho J, Park JJ, Jung KY · Trials (2026)

Participants: N/A
Duration: 4 weeks
Intervention: BELL-001 auditory neuromodulation-based prescription digital therapeutic delivering real-time biosignal-responsive acoustic feedback
Outcome: Change in Insomnia Severity Index (ISI) score from baseline to 4 weeks; secondary outcomes include response rate (ISI reduction ≥6 points), subjective sleep onset latency, wake after sleep onset, sleepiness, fatigue, depression, anxiety, quality of life, and work productivity
Effect Size: N/A
Population: Adults aged 19-75 years diagnosed with insomnia according to ICD-10 criteria (F51.0 or G47.0) and with an ISI score ≥15, from six clinical sites in the Republic of Korea

Result:

PubMed: 42426835DOI: 10.1186/s13063-026-09880-4

Mechanism Graph

Device detects real-time biosignals related to autonomic arousal
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Generates acoustic feedback responsive to those biosignals
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Induces autonomic downregulation through auditory neuromodulation
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Reduces hyperarousal, a core pathophysiological feature of insomnia

Limitations

  • ⚠Results are not yet available as this is a study protocol, not a completed trial
  • ⚠Sham-controlled design may not fully account for placebo effects of device-based interventions
  • ⚠Limited to Korean population, potentially reducing generalizability to other ethnic groups

Frequently Asked Questions

What is BELL-001?▼

BELL-001 is an auditory neuromodulation-based prescription digital therapeutic that uses real-time biosignal-responsive acoustic feedback to induce autonomic downregulation, targeting hyperarousal in insomnia.

How long is the treatment period in the SERENE trial?▼

The primary endpoint is assessed at 4 weeks from baseline, with the intervention delivered over that period.

What is the primary outcome measured in this study?▼

The primary outcome is the change in Insomnia Severity Index (ISI) score from baseline to 4 weeks.

Who is eligible to participate in the SERENE trial?▼

Adults aged 19-75 years with an ICD-10 diagnosis of insomnia (F51.0 or G47.0) and an ISI score of 15 or higher are eligible.

Products

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References

  1. 1.Kim K, Kim H, Kim H, Shin JW, Sunwoo JS, Byun JI, Hwang KJ, Ha J, Lee M, Cho J, Park JJ, Jung KY. "Auditory neuromodulation-based prescription digital therapeutic for insomnia disorder: study protocol for a randomized controlled trial (SERENE).." Trials, 2026. PMID: 42426835 DOI: 10.1186/s13063-026-09880-4
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.