SleepQ, a digital therapeutic (DTx) for insomnia jointly developed by Handok and WELT, surpassed 1,000 cumulative registrations with the National Evidence-based Healthcare Collaborating Agency (NECA) on the 3rd. NECA registration is an institutional procedure required for medical institutions to use digital therapeutics in actual clinical settings. SleepQ's passing of 1,000 NECA registrations is seen as an indication that a growing number of medical institutions are considering digital therapeutics as a new option for insomnia treatment.
According to the medical industry Wednesday, among the medical staff registered with NECA in connection with SleepQ, internal medicine accounted for the largest share at about 30%, while psychiatry and family medicine each accounted for about 12%.
In April, Handok strengthened its digital healthcare business by incorporating its digital healthcare division into its prescription drug organization, and it is bolstering communication with medical staff in the sleep health field, centered on SleepQ.
"SleepQ surpassing 1,000 NECA registrations is an achievement showing that digital therapeutics have entered a stage where they are being reviewed as a new option for insomnia treatment in clinical settings and are being prepared for adoption in earnest," said Kim Yun-mi, executive vice president of Handok's prescription drug business division. "Going forward, we will continue to expand medical accessibility so that insomnia patients can more easily access evidence-based cognitive behavioral therapy."
SleepQ is a prescription digital therapeutic that digitally implements cognitive behavioral therapy for insomnia (CBT-I), which is recommended as the standard for insomnia treatment. It received approval from the Ministry of Food and Drug Safety as Korea's first innovative medical device to pass integrated review. Used with a doctor's prescription, patients carry out evidence-based programs over six weeks, including sleep restriction, stimulus control, cognitive restructuring, relaxation therapy, and sleep hygiene education, which can help improve sleep habits. During the treatment period, the SleepQ Care Center conducts a total of three phone consultations to check sleep records and encourage patients' continued participation.
SleepQ's clinical efficacy was confirmed through domestic approval clinical trials. In the trials, patients using SleepQ showed a 15.14% improvement in sleep efficiency compared to baseline at seven weeks, and the time taken to fall asleep decreased from an average of 65.7 minutes to 35.8 minutes, an improvement of 29.8 minutes (about 45%). In addition, the DBAS-16 score, which assesses dysfunctional beliefs and attitudes about sleep, also improved with statistical significance.
