UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060496 |
|---|---|
| Receipt number | R000069208 |
| Scientific Title | Effect of Digital Device Interventions on Insomnia Symptoms among Working Women during Menopause: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/01/28 |
| Last modified on | 2026/01/28 12:47:20 |
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Basic information
Public title
Effect of Digital Device Interventions on Insomnia Symptoms among Working Women during Menopause: A Randomized Controlled Trial
Acronym
Effect of Digital Device Interventions on Insomnia Symptoms among Working Women during Menopause: A Randomized Controlled Trial
Scientific Title
Effect of Digital Device Interventions on Insomnia Symptoms among Working Women during Menopause: A Randomized Controlled Trial
Scientific Title:Acronym
Effect of Digital Device Interventions on Insomnia Symptoms among Working Women during Menopause: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Insomnia Symptoms
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effectiveness of digital CBT-based and mindfulness-based interventions among perimenopausal women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Insomnia Severity Index: ISI
Key secondary outcomes
1. Pittsburgh Sleep Quality Index: PSQI
2. Menopause Rating Scale: MRS
3. Work Functioning Impairment scale: WFun
4. Generalized Anxiety Disorder-7: GAD-7
5. Patient Health Questionnaire-9: PHQ-9
6. Five Facet Mindfulness Questionnaire: FFMQ
7. Cognitive Fusion Questionnaire: CFQ-7
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention using a Sleep diary integrated CBTI based application.
The sleep coaching program consists of a total of 26 tasks, including cognitive behavioral therapy components such as stimulus control and sleep restriction, stress reduction components such as relaxation, and sleep hygiene components. Participants select three tasks from the presented options and focus on them for four weeks. Each day, they report whether the tasks were implemented and record their sleep status using a sleep diary, including bedtime and wake-up time, sleep onset latency, nocturnal awakenings, and daytime vitality.
Interventions/Control_2
Duration: 4 weeks (28 days), approximately 5-10 minutes per day
Overall structure: A stepwise mindfulness program progressing from awareness of attention to meditation practice and generalization to daily life
Days 1-7 (Introduction and attention training)
Psychoeducation on the vicious cycle between menopausal symptoms and insomnia
Awareness of being caught up in thoughts and guided attention training (audio-based)
Days 8-15 (Meditation introduction)
Introduction of a three-step meditation (breath, bodily sensations, thoughts/emotions)
Days 16-21 (Meditation application)
Application of the three-step meditation in bedtime situations
Days 22-28 (Generalization to daily life)
Mindfulness practice during everyday activities (e.g., walking, household tasks)
Interventions/Control_3
Control group:
Use a sleep diary to record sleep status, including bedtime and wake-up time, sleep onset latency, awakenings during the night, and daytime energy levels.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 45 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Presence of at least mild menopausal symptoms: total MRS score >= 5
2. Presence of at least mild insomnia symptoms: ISI score >= 8
3. Not taking prescription hypnotics from medical institutions
4. Not taking over-the-counter sleep aids
Key exclusion criteria
1. History of post-traumatic stress disorder (PTSD) or depressive disorders (including suicidal ideation)
2. Sleep disorders other than insomnia (e.g., restless legs syndrome, sleep apnea syndrome)
3. Currently receiving pharmacotherapy with hypnotics or psychotherapy for sleep problems
4. Shift work employment
5. High risk of serious consequences due to sleep deprivation (e.g., truck drivers)
6. Major life events within the past month (e.g., hospitalization, bereavement)
7. Presence of systemic underlying diseases such as cancer or intractable disorders
8. History of surgical menopause or premature menopause
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Nomura |
Organization
Akita University
Division name
Department of Environmental Health Science and Public Health, Graduate School of Medicine
Zip code
0108543
Address
1-1-1, Hondo, Akita-shi, Akita
TEL
018-884-6087
knomura@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Songee |
| Middle name | |
| Last name | Jung |
Organization
Akita University
Division name
Department of Environmental Health Science and Public Health, Graduate School of Medicine
Zip code
0108543
Address
1-1-1, Hondo, Akita-shi, Akita
TEL
018-884-6087
Homepage URL
jonsoni@med.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Akita University Graduate School of Medicine and Faculty of Medicine
Address
1-1-1, Hondo, Akita-shi, Akita 010-8543
Tel
018-801-7127
soken@hos.akita-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 28 | Day |
Last modified on
| 2026 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069208
