A study of the efficacy of sleep behavior therapy using a sleep improvement app combined with light therapy to improve sleep problems in evening-type individuals: a pilot randomized controlled trial

UMIN ID: UMIN000053877

Registered date:15/03/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: sleep disturbance
• Date of first enrollment: 2023/10/03
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Sleep behavior therapy program 1.Sleep behavior therapy Intervention through the Sleep Healthy sleep improvement app. Send the following information daily by the app. (i) Recording a sleep diary. Input information such as bedtime and wake-up time. Based on the data entered, feedback is given on scores such as bedtime, actual sleep time, sleep efficiency and median sleep time. (ii) Sleep schedule to advance sleep phases. A sleep schedule is formulated using the app, and sleep behavior therapy is implemented to advance the waking and sleeping times by 30 minutes per day on weekdays and maintain the same rhythm on weekends. (iii) Information about sleeping. Provide information through columns, videos and quizzes. (iv) Stimulus control and progressive muscle relaxation methods Provide information through columns, videos and quizzes. 2.Light therapy 30 minutes of light therapy after waking up.
Not provide a remote Sleep behavior therapy program. Only recording sleep with portable activity monitor.

Outcome(s)

• Primary Outcome: Changes in the Insomnia Severity Index (ISI) during the four weeks intervention

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 39years-old
• Gender: Male and Female
• Exclude criteria: 1.Those for whom no improvement can be expected from the intervention Those with a time difference of more than 5 hours between their current average wake-up time and their target wake-up time. 2.Those who will be in significant time differences, such as overseas travel, during the study period. 3.Shift Workers 4.Those for which the safety of the intervention cannot be guaranteed. Photosensitivity. Having a serious preexisting condition. Those who has a treatment for sleep disorders. Those who has a treatment in psychiatry. Patient Health Questionnaire-9 (PHQ-9), Q9 "Thoughts that you would be better off dead or of hurting yourself in some way" is More than half the days in the past two weeks.

Related Information

• Primary Sponsor: Kyoto University
• Source(s) of Monetary Support: Nishikawa Foundation for Medical Promotion, Terumo life science foundation