Tokyo, April 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061344) titled 'Efficacy of digital brief behavioral treatment for insomnia using a smartphone application, with or without adjunctive light therapy, in individuals with insomnia symptoms and late chronotypes: a three-arm randomized controlled trial' on April 21.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Kyoto University

Condition: Condition - sleep disturbance Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to examine whether digital brief behavioral treatment for insomnia using a smartphone application, with or without adjunctive light therapy, can improve sleep and mental health in individuals with insomnia symptoms and late chronotypes. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 1. Digital brief behavioral treatment for insomnia Intervention using the sleep improvement app Sleep Healthy.

(i) Sleep schedule for phase advance After the second week, the sleep phase was advanced. The application individually notified participants of their target bedtime for that day and their target wake up time for the next morning.

(ii) Sleep education The application provided education for improving sleep through columns, videos, and sleep quizzes.

(iii) Recording a sleep diary Participants input information such as bedtime and wake up time. Based on the entered data, feedback was provided on scores such as bedtime, actual sleep time, sleep efficiency, and mid sleep time.

2. Light therapy Thirty minutes of light therapy after waking up.

3. Sleep recording All participants recorded their activity during the night while the lights were off using the FS-770. Interventions/Control_2 - 1. Digital brief behavioral treatment for insomnia Intervention using the sleep improvement app Sleep Healthy.

(i) Sleep schedule for phase advance After the second week, the sleep phase was advanced. The application individually notified participants of their target bedtime for that day and their target wake up time for the next morning.

(ii) Sleep education The application provided education for improving sleep through columns, videos, and sleep quizzes.

(iii) Recording a sleep diary Participants input information such as bedtime and wake up time. Based on the entered data, feedback was provided on scores such as bedtime, actual sleep time, sleep efficiency, and mid sleep time.

2. Sleep recording All participants recorded their activity during the night while the lights were off using the FS-770.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Individuals who fall under "definite evening type" or "moderate evening type," defined as having a Morningness-Eveningness Questionnaire (MEQ) score between 16 and 41 2. Individuals with an Insomnia Severity Index (ISI) score of 8 or higher 3. Individuals aged 18 years or older but younger than 40 years at the time of consent 4. Individuals who own a smartphone with a version and model compatible with the application 5. Individuals whose first language is Japanese Key exclusion criteria - 1. Individuals whose difference between current average wake-up time and target wake-up time exceeds 5 hours 2. Individuals who may experience significant time zone changes during the study period such as overseas travel Rationale: improvement through intervention is not expected 3. Individuals engaged in shift work or night work 4. Individuals with the following comorbid conditions: A. Those with photosensitivity B. Those with severe past medical history C. Those currently receiving treatment for insomnia or other sleep disorders D. Those undergoing outpatient treatment in psychosomatic medicine or psychiatry E. Individuals whose response frequency to Question 9 of the Patient Health Questionnaire-9 (PHQ-9)"Better off dead or thoughts of hurting yourself in some way" is "more than half the days" in the past two weeks Target Size - 90

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 03 Month 04 Day Date of IRB - 2026 Year 03 Month 04 Day Anticipated trial start date - 2026 Year 03 Month 05 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068528

Disclaimer: Curated by HT Syndication.