UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058098 |
|---|---|
| Receipt number | R000066395 |
| Scientific Title | Immediate effects of heart rate variability biofeedback on arousal and sustained attention |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2026/02/19 11:36:13 |
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Basic information
Public title
Immediate effects of heart rate variability biofeedback on arousal and sustained attention
Acronym
Immediate effects of heart rate variability biofeedback on arousal and sustained attention
Scientific Title
Immediate effects of heart rate variability biofeedback on arousal and sustained attention
Scientific Title:Acronym
Immediate effects of heart rate variability biofeedback on arousal and sustained attention
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether changes in arousal induced by heart rate variability biofeedback influence changes in sustained attention using electroencephalography (EEG) and the behavioral task.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Electroencephalogram during rest
Japanese version of Karolinska Sleepiness Scale (KSS-J)
Sustained attention to response task performance
Key secondary outcomes
Event-related potentials during sustained attention to response task
Heart rate variability during rest
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The 20-minute heart rate variability biofeedback training
Interventions/Control_2
The 20-minute paced breathing training at rest
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
1. Right-handed healthy adults
2. People who gave written informed consent based on their own free will
Key exclusion criteria
1. Medical history of psychiatric disorder or brain, heart, or respiratory diseases
2. History of dizziness and consciousness disorder due to controlled breathing
3. Consumption of drugs affecting the autonomic nervous system
4. Neurological or visual disability that interferes with behavioral tasks
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Saito |
Organization
Health Sciences University of Hokkaido
Division name
School of Rehabilitation Sciences
Zip code
061-0293
Address
1757, Kanazawa, Tobetsu, Hokkaido, Japan
TEL
0133-23-1486
r-saito@hoku-iryo-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryuji |
| Middle name | |
| Last name | Saito |
Organization
Health Sciences University of Hokkaido
Division name
School of Rehabilitation Sciences
Zip code
061-0293
Address
1757, Kanazawa, Tobetsu, Hokkaido, Japan
TEL
0133-23-1486
Homepage URL
r-saito@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Ryuji Saito
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Faculty of Health Sciences, Hokkaido University
Address
Nishi 5, Kita 12, Kita-ku, Sapporo, Hokkaido
Tel
011-706-3315
shomu@hs.hokudai.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
| 2025 | Year | 07 | Month | 01 | 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
A two-way mixed-design ANOVA with Group (HRVBF and control) and Time (pre and post) revealed significant main effects of Time on HRV, ERPs, SART performance, and KSS-J scores. However, no significant Group and Time interactions were observed for any outcome measures.
Polynomial regression analyses indicated a significant quadratic relationship between changes in resting-state EEG and SART performance, exclusively in the HRVBF group, whereas no significant relationships were observed in the control group.
Results date posted
| 2026 | Year | 02 | Month | 18 | Day |
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
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The heart rate variability biofeedback group will be divided into two groups using the median split method based on electroencephalogram indexes reflecting arousal levels, and a subgroup analysis will be performed to evaluate the effects on sustained attention.
Management information
Registered date
| 2025 | Year | 06 | Month | 05 | Day |
Last modified on
| 2026 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066395
