Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application - Trial NCT05991492

Timeline & Enrollment

Primary Outcome

Insomnia Severity Index (ISI)

Summary

Insomnia is an important public health problem and the most common sleep disorder in the
 general population. Up to 20% of adults in the United States suffer from insomnia disorder,
 and it has been associated with increased morbidity, mortality, and healthcare costs.
 Cognitive behavioral therapy for insomnia (CBT-I) is the initial recommended treatment
 approach for insomnia. Combined therapy with CBT-I and medication has shown no advantage over
 CBT-I alone. CBT-I is not always accessible to patients, however, due to cost and
 availability of trained healthcare professionals. Web-based CBT-I is an inexpensive and
 effective self-management tool for treatment of insomnia.
 
 This pilot study would test the efficacy of a new digital CBT-I application called Stellar
 Sleep, a cost effective and user-friendly version of wCBT-I, in patients with insomnia. This
 is the first digital CBT-I app that allows automatic entry of sleep diary data from wearable
 devices that track sleep (such as the Mi Band 5 or a FitBit, for instance). Testing the
 efficacy of this application will provide the preliminary data necessary for larger trials to
 further validate the application and determine its role for future patients. Use of this
 application can help bridge the gap in providing care to insomnia patients with
 transportation and cost barriers and to accommodate the long wait times for traditional
 in-person CBT-I. It will also be the first web-based CBT-I application that can directly
 upload data from a wearable device.

ICD-10 Classifications