Deep Brain Sound Stimulation for Sleep: Precision Auditory Stimulation

Background: Insomnia affects millions globally, significantly reducing quality of life and increasing the risk of mental and physical health issues. Traditional treatments, including Cognitive Behavioral Therapy for Insomnia (CBT-I) and pharmacotherapy, often face challenges related to accessibility, adherence, and side effects.Objective: This preliminary observational study evaluates the effectiveness and safety of Deep Brain Sound Stimulation (DBSS), a novel non-invasive auditory therapy, for individuals with insomnia and to enhance deep sleep based on user-reported outcomes.Methods: Data were collected from 358 users who completed DBSS therapy for Insomnia and Deep Sleep via the Vital Tones mobile application on the Apple App Store. Participants self- administered DBSS sessions at home and provided symptom reports through in-app surveys. User satisfaction was assessed using purchase and refund data, while symptom improvement was evaluated using descriptive statistics to determine median effectiveness and confidence intervals.Results: High user satisfaction was observed, with 99.30% of Insomnia users and 99.53% of Deep Sleep users satisfied with the treatment. Refund rates were exceptionally low, with only 0.70% (1/143) of Insomnia users and 0.47% (1/215) of Deep Sleep users requesting refunds. Among 19 survey respondents, the median symptom improvement was 80% for Insomnia (95% CI: 44.92%– 85.08%) and 65% for Deep Sleep (95% CI: 35.60%–94.40%). DBSS was well-tolerated, with no severe adverse events reported and only rare mild side effects such as transient dizziness and mild headaches.Conclusion: Preliminary findings suggest that DBSS is a promising non-invasive treatment for insomnia and enhancing deep sleep, offering significant symptom reduction and high user satisfaction. Its accessibility and favorable safety profile provide advantages over traditional therapies. However, the study’s observational design, limited survey sample, and reliance on self- reported data highlight the need for further controlled research to confirm DBSS’s efficacy and safety for sleep-related disorders.