Reported by Korea economy / May 17, 2023
Sleep specialized company, HoneyNaps, announced on the 17th that they have recently successfully completed clinical trials for their second-generation insomnia cognitive-behavioral therapy digital therapeutic device, in collaboration with Seoul Asan Hospital (led by Professor Seokhoon Jeong), to evaluate its effectiveness and safety for insomnia treatment.
The clinical trial was conducted using a randomized prospective double-blind design, comparing the safety and efficacy of a new digital therapeutic program (dSIBT-I) with the existing insomnia digital cognitive-behavioral therapy program (CBT-I). The purpose of the trial was to evaluate the safety and efficacy of the new treatment program.
The company explained that 50 insomnia patients were randomized controlled trial the dSIBT-I group, and sleep metrics were assessed on a weekly basis for both the treatment group and the control group over a period of one month. According to the company's explanation, both the dSIBT-I group and the control group showed significant improvement in the Insomnia Severity Index (ISI) scores, with no significant difference in patient compliance between the groups. However, starting from the second week, the dSIBT-I group exhibited significantly greater improvement compared to the control group, indicating substantial progress.
Sleep specialized company, HoneyNaps, has been at the forefront of developing second-generation digital therapeutics for insomnia.
Rather than relying on subjective sleep diaries and fragmented cognitive-behavioral therapy techniques, which the first generation utilized, HoneyNaps' second-generation digital therapeutics for insomnia takes a different approach. It incorporates objective patient sleep analysis data obtained through their self-developed non-contact sleep sensing device. By combining this objective sleep analysis data with AI technology, the system provides personalized treatment modules, maximizing patient compliance and treatment effectiveness.
HoneyNaps research director, Hodong YI said "We are currently engaged in validation clinical design work with Professor Seokhoon Jeong's team at Seoul Asan Hospital and a university hospital based in Seattle for FDA approval. We have signed MOU with domestic and global pharmaceutical companies for their second-generation dSIBT-I insomnia digital therapeutic device, SOMNUM Medella, and are currently in negotiations for licensing agreements."