UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053823 |
|---|---|
| Receipt number | R000061429 |
| Scientific Title | Research on the effects of acupuncture and moxibustion massage treatment on improving sleep |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2024/09/10 09:25:05 |
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Basic information
Public title
Research on the effects of acupuncture and moxibustion massage treatment on improving sleep
Acronym
Research on the effects of acupuncture and moxibustion massage treatment on improving sleep
Scientific Title
Research on the effects of acupuncture and moxibustion massage treatment on improving sleep
Scientific Title:Acronym
Research on the effects of acupuncture and moxibustion massage treatment on improving sleep
Region
| Japan |
Condition
Condition
sleep disorder
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying the Effect of Acupuncture and Massage Treatment on Sleep Improvement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG (Electroencephalography)
ACT (Actigraphy)
ECG (Electrocardiogram)
Key secondary outcomes
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
Treatment A => (washout period) => Treatment B
Interventions/Control_2
Treatment B => (washout period) => Treatment A
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy people outside the exclusion criteria
Key exclusion criteria
If the patient is on medication or other treatment for sleep disorders.
If the patient routinely takes sleeping pills.
If the patient is consuming excessive amounts of alcohol on a daily basis.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | TAKU |
| Middle name | |
| Last name | SAWANOBORI |
Organization
Fureasu Co.,Ltd.
Division name
Chairman and Representative Director
Zip code
141-0031
Address
2-27-3 Nishi-Gotanda, Shinagawa-ku, Tokyo
TEL
03-6632-9210
fcl@fureasu.jp
Public contact
Name of contact person
| 1st name | ASAMI |
| Middle name | |
| Last name | UCHIDA |
Organization
Fureasu Co.,Ltd.
Division name
Fureasu Co.,Ltd.
Zip code
151-0061
Address
2-5-8 Hatsudai, Shibuya-ku, Tokyo
TEL
03-6632-9210
Homepage URL
https://fureasu.jp/
uchida.asami@fureasu.jp
Sponsor or person
Institute
Fureasu Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Fureasu Co.,Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Brain Sleep Co. Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fureasu Co.,Ltd.
Address
2-27-3 Nishi-Gotanda, Shinagawa-ku, Tokyo
Tel
03-6632-9210
fcl@fureasu.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 | 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
10
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 | 02 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 11 | Day |
Last modified on
| 2024 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061429
