Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia

Insomnia Clinical Trial

Official title:

A Single-arm Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06339853
• Other study ID #: 1-2023-0023
• Status: Completed
• Phase: N/A
• Start date: September 7, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: March 2024
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study was to examine safety and efficacy of cognitive behavioral therapy (CBT)-based wearable integrated digital therapeutics for insomnia patients

Description:

The investigators intend to conduct a single-arm clinical trial. Following voluntary consent during the screening visit, participants will undergo screening procedures. The screening process will proceed step by step, evaluating selection/exclusion criteria through assessments such as the Mini International Neuropsychiatric Interview (MINI), Columbia Suicide Severity Rating Scale (C-SSRS), etc. Participants who meet the selection criteria and do not meet the exclusion criteria will use the DTx app for 8 weeks. Surveys conducted after app installation (Insomnia Severity Index (ISI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7-item Scale (GAD-7), and a sleep environment questionnaire) will serve as the baseline. During the clinical trial period, sleep diaries and compliance (lesson completion rate) (applicable only to the experimental group) will be collected through the app. Sleep diaries will be used to evaluate sleep metrics such as sleep efficiency (SE), sleep onset latency (SOL), wake after sleep onset (WASO), etc. For the experimental group, assessments as per the protocol will be conducted at baseline (Visit 1), and safety (adverse events) evaluation and termination of app usage will occur at 9 weeks (Visit 2).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Individuals aged 19 to 65 years old

2. DSM-5 insomnia disorder patient

3. ISI =11

4. Capable of using mobile device and application

Exclusion Criteria:

1. currently on non-pharmacological treatment for insomnia (ex. CBT-I, light therapy, oriental therapy for insomnia)

2. sleep disorders diagnosis other than insomnia (ex. Obstructive sleep apnea, sleep behavior problem, restless leg syndrome)

3. progressive and active medical conditions

4. received continuous psychotherapy such as CBT, motivational enhancement therapy, psychotherapy, and psychoanalysis in the past 3 months

5. major psychiatric illness as assessed through MINI

6. suicide risk as assessed through C-SSRS

7. having occupational risk due to sleep restriction

8. shift workers

9. PHQ-9 of 20 or above

10. Individuals who have actually slept less than an average of 5 hours per night over the past month

11. Pregnant women or individuals planning pregnancy during the clinical trial period

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• WELT-IP with wearable devices (Apple/galaxy watch. Oura ring)
WELT-IP (an investigational digital therapeutic) is an CBT-I based intervention designed to treat insomnia, conducted in 6 sessions. It is a comprehensive program delivering sleep restriction, stimulation control, muscle relaxation, cognitive treatment, and sleep hygiene education. Main features are sleep diary, sleep reports, daily lessons of CBT-I, muscle relaxation techniques, and cognitive intervention through chatbot. By using WELT-IP simultaneously with wearing an Apple Watch/Galaxy Watch and Oura Ring, sleep and environmental data can be collected.

Locations

Country	Name	City	State
Korea, Republic of	Department of Psychiatry, Severance Hospital	Seoul,

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 9 (post-treatment) of ISI	Change from baseline to week 9 (post-treatment) of ISI. ISI has 7 questions. Total score ranges from 0 to 28, where higher scores indicate more acute symptoms of insomnia.	9 weeks
Secondary	Secondary Outcome - Changes from baseline to week 9 of SE	Change from baseline to week 9 (post-treatment) of SE. Sleep efficiency is calculated as percentage of total sleep time/time in bed.	9 weeks
Secondary	Changes from baseline to week 9 of SOL.	Change from baseline to week 9 (post-treatment) of SOL. Sleep onset latency is evaluated as the time it takes a person to fall asleep after going to bed.	9 weeks
Secondary	Changes from baseline to week 9 of WASO.	Change from baseline to week 9 (post-treatment) of WASO. WASO is calculated as the total number of minutes that a person is awake after initially falling asleep.	9 weeks
Secondary	Changes from baseline to week 9 of PHQ-9.	Change from baseline to week 9 (post-treatment) of PHQ-9. PHQ-9 has nine questions. Total score ranges from 0 to 27, where higher scores indicate more acute symptoms of depression.	9 weeks
Secondary	Changes from baseline to week 9 of GAD-7.	Change from baseline to week 9 (post-treatment) of GAD-7. GAD-7 has seven questions. Total score ranges from 0 to 21, where higher scores indicate more acute symptoms of anxiety.	9 weeks
Secondary	Changes from baseline to week 9 of compliance.	Compliance (completion rate or lessons) Compliance is evaluated as completion rate of lessons.	9 weeks