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ACTIVE NOT RECRUITING
NCT05991492
NA

Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-02-13

Completion Date

2026-07

Last Updated

2026-01-30

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I

Digital insomnia treatment

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States