UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056811 |
|---|---|
| Receipt number | R000064932 |
| Scientific Title | Verification of sleep effect by neck back warming before bedtime |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2026/01/24 19:47:46 |
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Basic information
Public title
Verification of sleep effect by neck back warming before bedtime
Acronym
Verification of sleep effect by neck back warming
Scientific Title
Verification of sleep effect by neck back warming before bedtime
Scientific Title:Acronym
Verification of sleep effect by neck back warming
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate sleep by neck back warming before bedtime.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective Sleep Scores
Key secondary outcomes
- Pre-Sleep Arousal Scale
-Ford Insomnia Response to Stress Test
-Profiles of mood scale
-Sleep indicators by Fitbit
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
Placebo
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
1. Observation period for 1 week.
2. Applying warming sheet to neck back before bedtime for 4 weeks.
3. Follow up period for 2 weeks.
Interventions/Control_2
1. Observation period for 1 week.
2. Applying non-warming sheet to neck back before bedtime for 4 weeks.
3. Follow up period for 2 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Female aged 20-49
2. Female who has mild sleep difficulties
3. Person who agrees to use the wearable device (Fitbit)
Key exclusion criteria
1. Individuals with a history or current sleep disorders or psychiatric conditions.
2. Patients diagnosed with hypersomnia, sleep apnea, or sleep paralysis.
3. Those experiencing pain, itching, fever, diarrhea, or frequent urination that significantly disrupts sleep.
4. Individuals suffering from hay fever or allergic rhinitis that may disturb sleep.
5. Those with a history, current, or suspected cardiovascular diseases, neurological disorders, or alcohol dependence.
6. Individuals who smoke.
7. Those who regularly use medications, health supplements, or functional foods related to sleep, stress, or fatigue.
8. Individuals consuming more than the recommended alcohol amount (around 20g of pure alcohol daily) on more than three days a week, or who drink alcohol in bed.
9. Those who sleep less than 5 hours, or whose sleep wake times vary by more than 2 hours between weekdays and weekends.
10. Individuals working shifts or whose sleep schedules may change due to overseas business trips during the study period.
11. Those who develop eczema or hives when exposed to heat, or who are temperature-sensitive.
12. Individuals who have had allergic reactions (rashes, redness, itching) to medications or cosmetics.
13. Those with sensitive skin who may experience irritation from adhesive bandages or tapes.
14. Individuals with neck swelling or inflammation, cuts, grazes, eczema, or rashes.
15. Those who have experienced negative sensations or skin issues from heating pads or similar products in the past.
16. Pregnant individuals or those planning to become pregnant during the study.
17. Those uncomfortable sleeping with an activity monitor (Fitbit) that tracks sleep patterns.
18. Individuals currently participating in other studies or planning to during this study's participation.
19. Those deemed unsuitable for participation by the principal investigator for other reasons, including noncompliance with study protocols.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Miyauchi |
Organization
Kao Corporation
Division name
Human HealthCare Research Lab
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7271
miyauchi.yuki@kao.com
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Ichiba |
Organization
Kao Corporation
Division name
Human HealthCare Research Lab
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7271
Homepage URL
ichiba.tomohisa@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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 | 02 | Month | 01 | 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
Completed
Date of protocol fixation
| 2025 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 06 | 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 | 01 | Month | 24 | Day |
Last modified on
| 2026 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064932
