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NCT05991492Not yet recruiting

Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application

Brigham and Women's HospitalClinicalTrials.govdeviceDevice trial
Study focus
Disease/Condition
Insomnia
Drug/Device/Intervention
Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Brigham and Women's Hospital
Timeline & enrollment
Phase
N/A
Start date
Sep 01, 2023
End date
Jul 01, 2024
Enrollment
60 participants
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
Nonorganic insomniaDisorders of initiating and maintaining sleep [insomnias]Sleep disordersSleep disorder, unspecifiedOther sleep disorders
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05991492
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT05991492 through Pure Global AI's free database. This phase not specified trial is sponsored by Brigham and Women's Hospital and is currently Not yet recruiting. The study focuses on Insomnia. Target enrollment is 60 participants.

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