UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037619 |
|---|---|
| Receipt number | R000042830 |
| Scientific Title | Effects of plantar skin stimulation on sleep . |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2025/09/08 13:48:35 |
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Basic information
Public title
Effects of plantar skin stimulation on sleep .
Acronym
Effects of plantar skin stimulation on sleep.
Scientific Title
Effects of plantar skin stimulation on sleep .
Scientific Title:Acronym
Effects of plantar skin stimulation on sleep.
Region
| Japan |
Condition
Condition
insomnia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
One in five Japanese citizens has a sleep disorder, but many do not seek medical attention for it. Insomnia, the most common sleep disorder, is a risk factor for hypertension and is also linked to the onset of depression, making the study of sleep medicine essential. In modern society, where many people are busy working, it can be difficult to repeatedly visit acupuncture clinics or hospitals, so I thought it would be beneficial to find self-care methods for improvement and prevention during the periods between treatments. Based on this, I decided to examine the effects of continuous sleep control through self-care. Additionally, while indirect moxibustion, such as with a base moxa, is often used in self-care, the risk of burns makes it difficult for those with underlying health conditions. Therefore, I chose a method that involves applying non-invasive micro protrusions to acupuncture points considered effective for sleep on the soles of the feet, which previous research has suggested may be useful for falling asleep and maintaining sleep. This time, we decided to investigate the method using non-invasive micro protrusions for individuals with sleep disorders. Clinical research in acupuncture is often conducted within academic institutions, particularly targeting students, leading to significant bias and skepticism regarding its feasibility in clinical practice. In this study, in addition to our affiliated treatment center, we sought cooperation from an external group centered around female practitioners (Female Acupuncture Professionals Forum, led by Keiko Tsuchiuchi) to conduct case studies across multiple clinical institutions. Multi-site clinical research conducted by general treatment clinics is extremely rare, making the design of this study groundbreaking for the acupuncture industry.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Pittsburgh Sleep Quality Index
Key secondary outcomes
Sleep Feeling Survey upon Waking Up
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Non-invasive microprotrusions
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
There is a monthly menstrual period and the menstrual cycle is within the normal range.
Person with MDQ high price with menstrual symptoms
Person who has regular sleep habit but PSQI 10 points or more
Key exclusion criteria
Person with unstable sexual cycle
Those who are under the supervision of a doctor in the field of gynecology
Person who receives prescription of sleeping pill by doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Horikawa |
Organization
Morinomiya University of Medical Sciences
Division name
Faculty of Health and Medical Sciences
Zip code
559-8611
Address
1-26-16 Nankokita,Suminoe-ku,Osaka-shi,Osaka
TEL
06-6616-6911
horikawa@morinomiya-u.ac.jp
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Horikawa |
Organization
Morinomiya University of Medical Sciences
Division name
Faculty of Health and Medical Sciences
Zip code
559-8611
Address
1-26-16 Nankokita,Suminoe-ku,Osaka-shi,Osaka
TEL
0666166911
Homepage URL
horikawa@morinomiya-u.ac.jp
Sponsor or person
Institute
Morinomiya University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Morinomiya University of Medical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Women's oriental Medical Forum
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Morinomiya University of Medical Sciences
Address
1-26-16 Nankokita,Suminoe-ku,Osaka-shi,Osaka
Tel
06-6616-6911
horikawa@morinomiya-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
| 2021 | Year | 03 | Month | 31 | 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
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Due to the spread of the new coronavirus infection, it is difficult to recruit subjects.
Management information
Registered date
| 2019 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042830
