UMIN-CTR Clinical Trial

Public title

Acute effects of the 4-4-8 breathing technique on autonomic function, cardio-vascular dynamics, attention, and sleep quality

Acronym

Acute effects of the 4-4-8 breathing technique on autonomic function, cardio-vascular dynamics, attention, and sleep quality

Scientific Title

Acute effects of the 4-4-8 breathing technique on autonomic function, cardio-vascular dynamics, attention, and sleep quality

Scientific Title:Acronym

Acute effects of the 4-4-8 breathing technique on autonomic function, cardio-vascular dynamics, attention, and sleep quality

Region

Japan

Condition

Arteriosclerosis, sleep disorders

Classification by specialty

Medicine in general

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to examine the acute effects of the 4-4-8 breathing technique on autonomic function, circulatory dynamics, attention, and sleep quality.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

3 trials per participant on separate days.
1. Breathing exercises + no media equipment
2. Breathing exercises
3. Control

(1) Height, weight, body fat percentage, and body mass index will be measured.
(2) Arterial stiffness, blood pressure, heart rate, and autonomic nervous system function will be measured before and 30 and 60 minutes after the 4, 4, and 8 breathing exercises (no breathing exercises and seated rest for trial 3) for trials 1 and 2.
(3) Daily life while measuring autonomic nervous system function, body movement, and step count with a heart rate sensor. 4, 4, and 8 breathing exercises will be performed every hour until 17:00 for trials 1 and 2, and one hour before bedtime (trial 3 will not be performed).
(4) During bedtime, autonomic nervous system function, body movement, and blood pressure (at 2:00 and 4:00 a.m.) will be measured using a heart rate sensor and a wrist sphygmomanometer, respectively.
(5) In the morning of the next day, arterial stiffness, blood pressure, heart rate, autonomic nervous system function, and concentration will be measured.

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Breathing exercises and the use of media equipment are prohibited. At least 1 day of rest. Breathing exercises. At least 1 day of inactivity. Controls
The order depends on the participant.

Interventions/Control_2

Control. At least 1 day of inactivity. Breathing exercises and use of media equipment prohibited. At least 1 day of inactivity. Breathing exercises
The order depends on the participant.

Interventions/Control_3

Breathing. At least 1 day of rest. Control. At least 1 day of inactivity. Breathing exercises and use of media equipment prohibited.
The order depends on the participant.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

22

years-old

>=

Gender

Male

Key inclusion criteria

(1) Able to adjust the schedule
(2) Body mass index is less than 18.5-25kg/m2
(3) Those who can follow the precautions when participating in the experiment
(4) Those who have never smoked before.
(5) Have not had any abnormalities in X-rays or doctor's examinations within the past year
(6) Those who can prove a negative PCR test for the new type of coronavirus and proof of vaccination
(7) Those who do not have any difficulties in their studies (e.g., missing classes for research)
(8) Those who can keep the research conditions (sleeping hours, etc.)

Key exclusion criteria

(1) Subjects with serious physical disabilities that make it difficult for them to cooperate in the research
(2) Subjects who are using an implanted medical device such as a pacemaker
(3) Subjects taking medication or supplements
(4) Those who have an exercise habit
(5) Those who have not undergone a medical checkup within a year
(6) Those who have not undergone a medical checkup and cannot be confirmed as normal
(7) Those who cannot be proved negative by PCR test for novel coronavirus or proof of vaccination
(8) Those who cannot comply with research conditions (sleeping hours, etc.)
(9) Other cases in which the physician determines that participation in the study is inappropriate.

Target sample size

10

Name of lead principal investigator

1st name	Ryota
Middle name
Last name	Kobayashi

Organization

Teikyo University of Science

Division name

Center for Fundamental Education

Zip code

120-0045

Address

2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan

TEL

03-6910-1010

Email

rkobayashi@ntu.ac.jp

Name of contact person

1st name	Ryota
Middle name
Last name	Kobayashi

Organization

Teikyo University of Science

Division name

Center for Fundamental Education

Zip code

120-0045

Address

2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan

TEL

03-6910-1010

Homepage URL

Email

rkobayashi@ntu.ac.jp

Institute

Center for Fundamental Education, Teikyo University of Science

Institute

Department

Personal name

Kobayashi

Organization

Center for Fundamental Education, Teikyo University of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Teikyo University of Science

Address

2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan

Tel

03-6910-1010

Email

kenkyushien@ntu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

02

Month

28

Day

URL releasing protocol

https://medicalresearchjournal.org/index.php/GJMR/article/view/102426

Publication of results

Unpublished

URL related to results and publications

https://medicalresearchjournal.org/index.php/GJMR/article/view/102426

Number of participants that the trial has enrolled

7

Results

High-frequency (HF) components during sleep were significantly higher in the breathing technique and breathing technique + media device prohibition conditions compared to the control condition (P<0.05). Low-frequency (LF) components during sleep, the LF/HF ratio, and systolic blood pressure showed lower values in the breathing technique and breathing technique + media device prohibition conditions compared to the control condition (P<0.05).

Results date posted

2025

Year

10

Month

18

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Fifteen healthy male participants aged 19 to 20 years were recruited after obtaining informed consent. Prior to the study commencement, all participants received a complete verbal and written explanation of the purpose and methods of the analysis, followed by the acquisition of written informed consent. Subjects were young men with no medical history and in good health. Those with abnormal blood or urine test results, hypertension, abnormalities on chest X-ray or electrocardiogram, and those taking medications that could affect blood pressure were excluded.

Participant flow

Individuals with abnormal blood or urine test results, hypertension, abnormal chest X-rays or electrocardiograms, and those taking medications that could affect blood pressure were excluded.

Adverse events

For this study, sleep duration will be adjusted for the 7 days prior to measurement. While we do not anticipate this sleep adjustment causing undue burden to participants, those experiencing significant burden will be excluded from the study. If participants are unable to maintain the required sleep duration due to personal circumstances, they must report this to the examiner. In such cases, minor adjustments will be made on an alternate day, or the measurement will be discontinued. Measurements will be conducted using equipment verified as safe through operational checks, in a hygienic environment consistent with methods commonly used in research or clinical settings, with consideration for the subject's physical condition. Subjects will be informed that, although extremely unlikely, temporary arm numbness may occur during arterial stiffness measurement. Furthermore, while no significant physical or mental burden or discomfort is anticipated for subjects during data collection for this study, measurements will be discontinued if a subject feels unwell or experiences a sudden change in condition on the day of measurement. If measurement is discontinued due to a sudden change in condition, the subject will be transported to the university health center or hospital as necessary and monitored until their condition recovers.

Outcome measures

Height, weight, body fat percentage, body mass index, autonomic nervous function (heart rate variability), heart rate, systolic blood pressure, diastolic blood pressure, brachial-ankle pulse wave velocity, and concentration

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2022

Year

04

Month

01

Day

Date of IRB

2022

Year

06

Month

08

Day

Anticipated trial start date

2022

Year

08

Month

01

Day

Last follow-up date

2022

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

02

Month

27

Day

Last modified on

2025

Year

10

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056924