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.
This article is automatically generated from the structured evidence profile behind the claim above. Scores reflect the quality and quantity of available research, not clinical advice.
Auditory neuromodulation-based PDT (BELL-001) reduces insomnia severity in adults with insomnia disorder The current body of evidence comprises 1 study, including 1 randomized controlled trial. EvidenceHub rates the overall confidence at 42/100 (low).
The Claim
Auditory neuromodulation-based PDT (BELL-001) reduces insomnia severity in adults with insomnia disorder
This conclusion is most relevant to: 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.
What the Research Shows
The conclusion draws on 1 linked study. Highlights from the cited literature:
- ▸Auditory neuromodulation-based prescription digital therapeutic for insomnia disorder: study protocol for a randomized controlled trial (SERENE). (Trials, 2026) —
How It Works
The proposed biological pathway:
- ▸Device detects real-time biosignals related to autonomic arousal
- ▸Generates acoustic feedback responsive to those biosignals
- ▸Induces autonomic downregulation through auditory neuromodulation
- ▸Reduces hyperarousal, a core pathophysiological feature of insomnia
Who Might Benefit
Evidence fit by 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
Recommended Dose
N/A
Limitations & Caveats
Important context when interpreting this evidence:
- ▸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.
References
- 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