UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058183 |
|---|---|
| Receipt number | R000066514 |
| Scientific Title | Assessing the Effectiveness of Digital CBT-I in Enhancing Sleep for Pregnant Women |
| Date of disclosure of the study information | 2025/06/23 |
| Last modified on | 2025/06/16 11:25:02 |
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Basic information
Public title
Assessing the Effectiveness of Digital CBT-I in Enhancing Sleep for Pregnant Women
Acronym
dCBT-I for Pregnant Women
Scientific Title
Assessing the Effectiveness of Digital CBT-I in Enhancing Sleep for Pregnant Women
Scientific Title:Acronym
dCBT-I for Pregnant Women
Region
| Japan |
Condition
Condition
Healthy pregnant women and infants
Classification by specialty
| Gastroenterology | Obstetrics and Gynecology | Nursing |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of digital CBT-I, designed to support pregnant women in improving their sleep habits during the mid-pregnancy period, on sleep quality in late pregnancy. Additionally, it examines the potential benefits of this intervention in postpartum sleep improvement and the prevention of depression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of sleep disorders during late pregnancy
Key secondary outcomes
Incidence of sleep disorders at 1 month and 6 months postpartum, the 3D sleep scale, sleep duration and nighttime awakenings, the Edinburgh Postnatal Depression Scale, and pregnancy and delivery complications.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Implementing dCBT-I using a smartphone app.
Interventions/Control_2
Interventions/Control_3
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Pregnant women currently receiving outpatient treatment at the Department of Obstetrics and Gynecology at Kyushu University Hospital
2. Patients who fully understand the research plan and are able to give their own informed consent
Key exclusion criteria
1. Patients diagnosed with insomnia, restless legs syndrome, or sleep apnea syndrome
2. Patients taking sleeping pills
3. Patients with psychiatric disorders (depression, panic disorder, etc.)
4. Patients with high-risk pregnancies (pregnancy-induced hypertension, heart disease, epilepsy, etc.)
5. Multiple pregnancies
6. Patients who are deemed inappropriate for clinical practice by researchers or physicians
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Seiichi |
| Middle name | |
| Last name | Morokuma |
Organization
Kyushu University
Division name
Department of Health Sciences, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
+81-92-642-6708
morokuma.seiichi.845@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiichi |
| Middle name | |
| Last name | Morokuma |
Organization
Kyushu University
Division name
Department of Health Sciences, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
+81-92-642-6708
Homepage URL
morokuma.seiichi.845@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Seiichi Morokuma
Funding Source
Organization
Kyushu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Boards / Ethics Committees of Kyushu University Hospital and Medical Institutions
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN
Tel
+81-92-642-5082
byskenkyu@jimu.kyushu-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
| 2025 | Year | 06 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 16 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066514
