UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055287 |
|---|---|
| Receipt number | R000063169 |
| Scientific Title | Effects of using the test product on sleep quality in healthy Japanese: a randomized, no treatment-controlled, open-labeled, parallel-group comparison study |
| Date of disclosure of the study information | 2024/08/20 |
| Last modified on | 2025/03/17 15:29:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of using the test product on sleep quality in healthy Japanese
Acronym
Effects of using the test product on sleep quality in healthy Japanese
Scientific Title
Effects of using the test product on sleep quality in healthy Japanese: a randomized, no treatment-controlled, open-labeled, parallel-group comparison study
Scientific Title:Acronym
Effects of using the test product on sleep quality in healthy Japanese
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of using the test product on sleep quality in healthy Japanese.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured values of "sleepiness on rising," "initiation and maintenance of sleep," "frequent dreaming," "refreshing," "sleep length," and each item in the OSA sleep inventory MA version (OSA-MA) at four weeks after intervention (4w)
Key secondary outcomes
1. Individuals whose answers to original questionnaire ("My whole body is cold," "My fingers and toes are cold," "My body temperature is not stable," "My body feels heavy," "I feel irritated," "I feel malaise," "I have lower back pain and shoulder stiffness," "I have trouble falling asleep," "My sleep is light," and "I wake up in my sleep") are improved by one or more levels at 4w
2. The measured values of sleep scan (measurement time, sleep score, total bedtime, sleep onset latency, total sleep time, actual sleep time, sleep efficiency, wake time after sleep onset, number of waking up, the time of microarousal, number of microarousal, rapid eye movements (REM) sleep latency, latency to deep sleep, amount of arousal appearance, rate of arousal appearance, amount of REM appearance, rate of REM appearance, amount of light sleep appearance, rate of light sleep appearance, amount of deep sleep appearance, rate of deep sleep, number of sleep-stage transition, number of arousal-stage appearance, number of REM sleep-stage appearance, number of light sleep-stage appearance, number of deep sleep-stage appearance, rate of deep sleep (the first half), rate of deep sleep (the latter half), mean pulse rate, maximal pulse rate, minimal pulse rate, sleep cycle, number of body motion detection, sleep depth score, sleep cycle score, sleep time score, wake after sleep onset score) at 4w
3. The measured value of body temperature at 4w
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Duration: Four weeks
Test product: Electric potential therapy instrument TSUBAKI 14000
Administration: Use daily between dinner and bedtime, seated in a chair or on the floor for 60 minutes.
*If you forget to use the test product, use it as soon as you remember within the day. If you cannot use it, record it in the diary.
Interventions/Control_2
Duration: Four weeks
No treatment
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Individuals aged 40 or more
4. Healthy individuals
5. Individuals who are concerned about their sleep quality
6. Individuals who have low Zc score of "initiation and maintenance of sleep" in the OSA-MA at screening (before intervention)
Key exclusion criteria
Individuals who
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. are taking or using medications (including herbal medicines) and supplements
6. are allergic to medicines and foods related to the test product
7. live with infants less than one year old
8. sleep with children (1 to 6 years old)
9. live with requiring long-term care persons
10. sleep with more than one person
11. have irregular sleeping time or habit due to work such as a late-night shift
12. have nocturia three times or more
13. are restricted from daily intense physical activity due to diseases or other reasons
14. are using a wearable medical electrical equipment, such as an electrocardiograph
15. need to rest
16. have temperature sensory loss
17. have sleep apnea syndrome
18. are taking antithrombotic drugs or undergoing medical treatment for hematogenous disorders
19. may be jumped on or suddenly touched by persons, objects, or pets while using the test product
20. cannot use the test product with a proper understanding of its use and precautions
21. are pregnant, lactating, or planning to become pregnant during this study
22. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
23. are judged as ineligible to participate in this study by the physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Cosmogoodness Pte. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 20 | 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
56
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
| 2024 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 20 | Day |
Last modified on
| 2025 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063169
