Handok and Welt's digital therapeutic device (DTx) SleepQ has surpassed 1,000 registrations with the National Evidence-based Healthcare Collaborating Agency (NECA). This milestone reflects the growing acceptance of digital therapeutic devices as a new option for treating insomnia.
On July 8, Handok and Welt announced that SleepQ reached the cumulative total of 1,000 registrations with NECA on July 3.
NECA registration is a procedural requirement for medical institutions to utilize digital therapeutic devices in actual clinical practice. The companies explained that surpassing 1,000 registrations indicates an increasing number of healthcare providers considering digital therapeutic devices as a viable option for insomnia treatment.
Among the medical professionals registered with NECA for SleepQ, approximately 30% are from internal medicine, while psychiatry and family medicine each account for about 12%.
In April, Handok integrated its digital healthcare division into its prescription drug organization, enhancing communication with healthcare professionals in the sleep health sector, focusing on SleepQ.
SleepQ is a prescription digital therapeutic device that implements cognitive behavioral therapy for insomnia (CBT-I), which is recommended as the standard treatment for insomnia. It has been approved as the first innovative medical device by the Ministry of Food and Drug Safety. Under medical supervision, it offers a six-week evidence-based program that includes sleep restriction, stimulus control, cognitive restructuring, relaxation techniques, and sleep hygiene education, along with three phone consultations during the treatment period.
In domestic clinical trials, patients using SleepQ showed a 15.14% improvement in sleep efficiency at the seven-week mark compared to baseline, and the time taken to fall asleep decreased from an average of 65.7 minutes to 35.8 minutes, a reduction of about 45%. The DBAS-16 score, which assesses dysfunctional beliefs and attitudes about sleep, also showed statistically significant improvement.
Since the first prescription of SleepQ in April 2024, Handok and Welt have been actively exploring various initiatives to expand its use. Considering the characteristics of digital healthcare, they initially focused on accumulating usage cases through accessible telemedicine, and recently, they have also been expanding prescriptions in face-to-face consultations.
Kim Yoon-mi, Executive Director of Handok's Prescription Drug Division, stated, "The surpassing of 1,000 NECA registrations for SleepQ demonstrates that digital therapeutic devices are entering a stage where they are being seriously considered and prepared for implementation in the treatment of insomnia. We will continue to enhance accessibility for insomnia patients to receive evidence-based cognitive behavioral therapy more easily."
* This article has been translated by AI.
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