#HoneyNaps #SOMNUM #AI Sleep

Transforming Clinical Trials: HoneyNaps' SOMNUM AI

In a groundbreaking development, HoneyNaps, a company pioneering AI technology in sleep medicine, has announced the launch of its FDA-cleared diagnostic support software, SOMNUM™. This innovative solution is set to revolutionize the landscape of clinical trials by significantly reducing the time and cost traditionally associated with sleep disorder research.

The Efficiency Booster for Clinical Trials

The primary advantage of SOMNUM™ lies in its ability to automate the analysis of polysomnography (PSG) data, a crucial aspect of understanding sleep conditions. Historically, PSG scoring required specialists to invest three to four hours manually reviewing and classifying data per case. With SOMNUM™, the scoring process is expedited to mere minutes.

This rapid analysis not only enhances productivity but also allows clinicians to dedicate more time to verifying results instead of mere scoring. By integrating SOMNUM™, pharmaceutical companies and medical device manufacturers can now accelerate their clinical trial pipelines, increasing data-processing speeds by over 70% and slashing study timelines by approximately 50%. The financial implications are significant too, with labor costs for scoring and quality control expenses reduced by 80-90%.

Validated by Regulatory Authorities

Following its FDA 510(k) clearance, SOMNUM™ has been formally recognized as a validated analytical tool for clinical trials related to sleep disorders. This recognition underscores the safety and reliability of AI technology for sleep analysis, ensuring that pharmaceutical and medical device companies can trust the data generated during their studies.

As HoneyNaps expands its global clinical market presence, SOMNUM™ remains central to the company’s strategic vision. The company is actively engaging with numerous U.S. pharmaceutical firms to explore the application of SOMNUM™ in sleep-related studies.

Strategic Collaboration and AI Enhancements

HoneyNaps has also formed strategic partnerships with multiple Clinical Research Organizations (CROs), providing a comprehensive biosignal-analysis platform essential for sleep medicine trials. These collaborations empower HoneyNaps to offer real-time data analysis and improve the accuracy of clinical study outcomes, prompting enhanced decision-making capabilities.

Additionally, HoneyNaps has introduced an AI-based verification scoring service that compliments their existing offerings. This service allows CROs to re-check previously scored PSG datasets for accuracy, thereby assuring clients of data integrity while bolstering confidence in submissions to regulatory bodies. This unique approach not only verifies past cases but aids in advancing future projects, technology development, and proprietary algorithms.

Explainable AI for Transparency

A notable feature of SOMNUM™ is its employment of explainable AI (XAI) technology. This aspect allows clinicians to understand the rationale behind the AI's scoring decisions, fostering transparency in trial data—an essential requisite for maintaining compliance with stringent regulatory standards.

Collaboration with renowned hospitals and clinical institutions across Korea, the U.S., and Europe is already underway, ensuring that SOMNUM™ will contribute to a wide array of clinical trials. Whether evaluating the effectiveness of CPAP devices, wearable technologies, or new sleep therapeutics, SOMNUM™ is at the forefront of a new era in sleep medicine.

In reflecting on the impact of this advanced AI technology, Taekyoung (Sean) Ha, PhD, President of HoneyNaps USA, expressed, “SOMNUM's PSG AI scoring technology is fundamentally transforming the traditionally time-consuming manual scoring process that has long been a bottleneck in sleep-related clinical trials.