ArticleTrials2026
Auditory neuromodulation-based prescription digital therapeutic for insomnia disorder: study protocol for a randomized controlled trial (SERENE).
Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07295431 (A Multicenter, Randomized, Double-Blind, Sham-Controlled, Pivotal Clinical Investigation to Evaluate the Efficacy and Safety of the Digital Therapeutic 'BELL-001' for Improving Symptoms in Patients With Insomnia), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Randomized, Double-Blind, Sham-Controlled, Pivotal Clinical Investigation to Evaluate the Efficacy and Safety of the Digital Therapeutic 'BELL-001' for Improving Symptoms in Patients With Insomnia
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInsomnia 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.
methodsThis 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.