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
Verified date | March 2024 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study was to examine safety and efficacy of cognitive behavioral therapy (CBT)-based wearable integrated digital therapeutics for insomnia patients
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Psychiatry, Severance Hospital | Seoul, |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT05963542 -
Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia
|
N/A | |
Recruiting |
NCT04069247 -
Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia
|
N/A | |
Completed |
NCT04493593 -
Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility
|
N/A | |
Recruiting |
NCT06278077 -
Neurexan - a Clinical Trial in Short-Term Insomnia Patients
|
Phase 2 | |
Recruiting |
NCT05956886 -
Sleep Chatbot Intervention for Emerging Black/African American Adults
|
N/A | |
Completed |
NCT04661306 -
The Better Sleep for Supporters With Insomnia Study
|
N/A | |
Recruiting |
NCT06207279 -
Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
|
||
Recruiting |
NCT06006299 -
Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)
|
N/A | |
Completed |
NCT03683381 -
App-based Intervention for Treating Insomnia Among Patients With Epilepsy
|
N/A | |
Completed |
NCT04564807 -
Testing an Online Insomnia Intervention
|
N/A | |
Completed |
NCT03673397 -
The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression
|
N/A | |
Completed |
NCT04035200 -
Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation
|
Phase 2 | |
Active, not recruiting |
NCT05027438 -
Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention
|
N/A | |
Recruiting |
NCT06053840 -
An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia
|
Phase 4 | |
Not yet recruiting |
NCT06348082 -
Project Women's Insomnia Sleep Health Equity Study (WISHES)
|
N/A | |
Not yet recruiting |
NCT06363799 -
Osteopathic Protocol for Insomnia in College Students
|
N/A | |
Not yet recruiting |
NCT05991492 -
Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application
|
N/A | |
Not yet recruiting |
NCT06025968 -
Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis
|
N/A | |
Not yet recruiting |
NCT03194191 -
Pregnancy With Insomnia: a Trial of Acupuncture
|
N/A |