What question did this study set out to answer?

This trial aims to evaluate the efficacy and safety of BELL-001, a digital therapeutic for insomnia, in adults.

May 10, 2026SLEEP

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

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

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.

Kim et al. (2026) studied this question.

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May 10, 2026SLEEP

View Full Paper

Ask AI

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Authors

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

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.

Kim et al. (2026) studied this question.

View Full Paper

Ask AI

Bookmark