UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063296 |
|---|---|
| Receipt number | R000072455 |
| Scientific Title | The Effects of Breath-Holding on Spinal Neural Function |
| Date of disclosure of the study information | 2026/10/15 |
| Last modified on | 2026/10/15 17:13:50 |
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Basic information
Public title
The Effects of Breath-Holding on Spinal Neural Function
Acronym
The Effects of Breath-Holding on Spinal Neural Function
Scientific Title
The Effects of Breath-Holding on Spinal Neural Function
Scientific Title:Acronym
The Effects of Breath-Holding on Spinal Neural Function
Region
| Japan |
Condition
Condition
Healthy persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of breath-holding on spinal motoneuron excitability and spinal reciprocal inhibition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in spinal motoneuron excitability
Changes in spinal reciprocal inhibition
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
| Other |
Interventions/Control_1
Resting breathing
Interventions/Control_2
Breath-holding
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy persons aged 18-30 years
Key exclusion criteria
Individuals with central nervous system diseases, cardiac diseases, respiratory diseases, orthopedic diseases, peripheral neuropathies, or other relevant medical conditions; those with a history of syncope or hyperventilation attacks; those with skin diseases or wounds at the stimulation sites; and those using implantable medical devices
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Suzuna |
| Middle name | |
| Last name | Tokunaga |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
0252574451
hpm26007@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Suzuna |
| Middle name | |
| Last name | Tokunaga |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
0252574451
Homepage URL
hpm26007@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Ethics Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
Tel
0252574455
rinri@nuhw.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
| 2026 | Year | 10 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 15 | Day |
Last modified on
| 2026 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072455
