UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055974 |
|---|---|
| Receipt number | R000063913 |
| Scientific Title | Effects of scalp electroacupuncture stimulation on sleep in subjects with insomnia: a randomized crossover study |
| Date of disclosure of the study information | 2024/10/30 |
| Last modified on | 2026/02/18 09:55:41 |
* 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 scalp electroacupuncture stimulation on sleep in subjects with insomnia: a randomized crossover study
Acronym
Effects of scalp electroacupuncture stimulation on sleep in subjects with insomnia: a randomized crossover study
Scientific Title
Effects of scalp electroacupuncture stimulation on sleep in subjects with insomnia: a randomized crossover study
Scientific Title:Acronym
Effects of scalp electroacupuncture stimulation on sleep in subjects with insomnia: a randomized crossover study
Region
| Japan |
Condition
Condition
no disease
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the changes in subjective and objective sleep conditions induced by scalp electroacupuncture in individuals with self-reported insomnia symptoms
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Restorative Sleep Questionnaire(RSQ)
Key secondary outcomes
Epworth sleepiness Scale Japanese Ver
Sleep EEG
Athens Insomnia Scale
Physical activity
harmful phenomenon
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
scalp electroacupuncture
Interventions/Control_2
no stimulation
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
| Not applicable |
Gender
Male
Key inclusion criteria
"Male adults aged 18 years or older at the time of consent.
Self-reported insomnia lasting for more than one month.
Athens Insomnia Scale score of 6 or higher, but less than 16.
Capable of providing written consent based on their free will after receiving a thorough explanation of the study
Key exclusion criteria
History of psychiatric disorders.
Presence of cerebrovascular disorders, malignancies, or other severe physical diseases.
Use of sleeping pills, anti-anxiety medications, or antidepressants.
Use of a cardiac pacemaker or an implantable defibrillator.
Irregular lifestyle habits, such as working night shifts at least once per week
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Sakai |
Organization
Tokyo Ariake University
Division name
Faculty of Health Sciences, Department of Acupuncture and Moxibustion
Zip code
135-0063
Address
2-9-1 Ariake, Koto-ku, Tokyo
TEL
03-6703-7000
sakai@tau.ac.jp
Public contact
Name of contact person
| 1st name | Kazutoshi |
| Middle name | |
| Last name | Toyoda |
Organization
Graduate School of Tokyo Ariake University
Division name
Graduate School of Health Care Medicine
Zip code
135-0063
Address
2-9-1 Ariake, Koto-ku, Tokyo
TEL
03-6703-7000
Homepage URL
5124001@tau.ac.jp
Sponsor or person
Institute
Tokyo Ariake University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Ariake 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
Tokyo Ariake University School of Medicine Ethics Review Committee
Address
2-9-1 Ariake, Koto-ku, Tokyo
Tel
0367037000
akiyama@tau.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
| 2024 | Year | 10 | Month | 30 | 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
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 01 | 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 | 10 | Month | 29 | Day |
Last modified on
| 2026 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063913
