SleepQ, Digital Therapeutic Device for Insomnia, Launches Full-Scale Clinical Trial in Germany

Handok and Welt Assess Efficacy and Safety in Adult Patients

Handok announced on January 19 that SleepQ, a digital therapeutic device for insomnia developed in collaboration with Welt, has completed the first patient enrollment in a clinical trial for adult insomnia patients currently underway in Germany as of last month.

This clinical trial is a randomized controlled study designed to evaluate the efficacy and safety of SleepQ, a digital cognitive behavioral therapy for insomnia (CBT-I) app, in adults aged 18 and older with insomnia. A total of 80 patients with insomnia are being recruited in Germany, and the study will run for 12 weeks. The experimental group will use SleepQ in addition to standard care, while the control group will receive only standard care, allowing for a one-to-one comparison. All assessments are conducted remotely, and changes in insomnia symptoms are measured using the internationally recognized Insomnia Severity Index (ISI).

The German clinical trial for SleepQ is being conducted at Charit?, the largest university hospital in Europe. The study aims to verify the overall clinical effects of digital therapeutics by evaluating not only improvements in insomnia symptoms but also indicators such as depression, anxiety, sleep perception distortion, daily functioning, and quality of life.

This clinical trial serves as a pilot study for the inclusion of SleepQ in the DiGA registry in Germany. DiGA is a digital healthcare app prescription and insurance reimbursement system, first introduced in Germany in 2019, under which physicians can prescribe digital therapeutic devices and public health insurance covers the cost. Through this trial, the company plans to systematically confirm the positive health effects that SleepQ can provide to patients in real-world medical settings and to establish key evidence for confirmatory clinical trials and insurance listing.

Kang Sungji, CEO of Welt, stated, "It is highly significant to begin clinical trials in Germany, a global leader in digital healthcare," adding, "We will do our best to demonstrate the excellence of SleepQ through this trial and ensure that Korean digital therapeutics are recognized in the global market."

SleepQ is the first innovative medical device to receive integrated review approval from the Ministry of Food and Drug Safety for the treatment of insomnia. It digitizes cognitive behavioral therapy for insomnia, previously only available in hospitals, and provides it in the form of a smartphone app. After a medical consultation, patients can receive a prescription and undergo a six-week therapy program to fundamentally correct their sleep habits. SleepQ collects a wide range of patient data and analyzes sleep patterns to provide personalized treatment, including sleep restriction, stimulus control, cognitive restructuring, relaxation techniques, and sleep hygiene education.

In a previous regulatory clinical trial involving insomnia patients, the group treated with SleepQ showed an improvement in sleep efficiency ratio of approximately 15.14% compared to baseline at the seven-week mark. SleepQ received CE certification in Europe in September last year and obtained ISO 27001 certification, the international standard for information security management systems, in November, meeting global standards.