Genetic Predisposition to DiseaseNCT07018128
Expression of Genes Relating Hypertension and Efficacy of 4-7-8 Breathing Control on Reducing Blood Pressure
A study testing Study 2: deep breathing, Study 2: 4-7-8 breathing and Study 2: slow breathing with device in people with Genetic Predisposition to Disease and Breathing, Mouth, run by Burapha University at 1 site in Thailand.
Trial summary
This study consists of two sub-studies. Study 1 investigates gene expression related to the development of hypertension in Thailand, and Study 2 examines the effectiveness of the 4-7-8 breathing technique in reducing blood pressure in individuals with hypertension. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Genetic Predisposition to Disease, Breathing, Mouth
- What is being tested?
- Study 2: deep breathing, Study 2: 4-7-8 breathing and Study 2: slow breathing with device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- Aged between 18-59 years
- Of Thai ethnicity
- Diagnosed with hypertension, defined as having an SBP of 140 mmHg or higher, or a DBP of 90 mmHg or higher, or having previously been diagnosed with hypertension and currently taking antihypertensive medication
- Originally from various regions of Thailand and currently residing in the eastern region
- Male or female
Show all 14Show fewer
- Aged between 18-59 years
- Of Thai ethnicity
- Does not have hypertension, defined as having an SBP below 130 mmHg and a DBP below 85 mmHg, with no prior diagnosis of hypertension and no history of taking antihypertensive medication
- Originally from various regions of Thailand and currently residing in the eastern region
- Male or female, aged 35-59 years
- Diagnosed with hypertension, with blood pressure levels above the normal range, defined as SBP of 130 mmHg or higher, or DBP of 85 mmHg or higher, and currently taking medication
- Originally from various regions of Thailand and currently residing in the eastern region
- Able to communicate effectively
Who cannot join
- Has heart disease, such as valvular stenosis or regurgitation, coronary artery disease, or heart failure
- Has obesity, defined as having a body mass index (BMI) of 30 kg/m² or higher
- Has a fever or is currently experiencing an infectious disease, such as COVID-19, the flu, or other infections
- Group of individuals with normal blood pressure
- Has heart disease, such as valvular stenosis or regurgitation, coronary artery disease, or heart failure
- Has obesity, defined as having a body mass index (BMI) of 30 kg/m² or higher
Show all 12Show fewer
- Has a fever or is currently experiencing an infectious disease, such as COVID-19, the flu, or other infections
- Study 2:
- Has respiratory diseases, cardiovascular diseases, cerebrovascular disease, kidney disease, cancer, or immune-related conditions such as allergies, autoimmune diseases (e.g., SLE), immunodeficiency, or rheumatoid arthritis
- Is obese, defined as having a body mass index (BMI) of 30 kg/m² or higher
- Has a fever or is currently infected, such as with COVID-19, the flu, or other infectious diseases
- Is currently pregnant, breastfeeding, or has a history of pregnancy within the 6 months prior to participating in the study
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Allied Health Sciences, Burapha University
MueangChonburi, Changwat Chon Buri, 20131
About this study
Official title: Expression of Genes Relating Hypertension in Thailand and the Efficacy of 4-7-8 Breathing Control on Reducing Blood Pressure in Individuals With Hypertension
This study consists of two sub-studies. Study 1 investigates gene expression related to the development of hypertension in Thailand, and Study 2 examines the effectiveness of the 4-7-8 breathing technique in reducing blood pressure in individuals with hypertension.
Read the detailed description
In Study 1, the sample group includes 200 individuals aged 18-59 years, originating from various regions of Thailand but currently residing in the eastern region. Participants may have normal blood pressure, high blood pressure, or have been diagnosed with hypertension. Blood samples from the participants will be analyzed for the following variables: 1) expression of five genes-adrenomedullin (ADM), angiopoietin-like 4 (ANGPTL4), proto-oncogene c-Fos (FOS), prostaglandin-endoperoxide synthase 2 (PTGS2), and ubiquitin specific peptidase 8 (USP8), and 2) markers of inflammation-tumor necrosis factor-alpha and interferon-gamma levels in the blood.
In Study 2, the sample group includes 75 volunteers from Study 1 who are interested in participating. These volunteers will be randomly assigned into three groups of 25 people each. The first group is a control group whose participants will not receive any breathing training. The second group will practice the 4-7-8 breathing technique, which involves inhaling for 4 seconds, holding the breath for 7 seconds, and exhaling for 8 seconds-this constitutes one cycle. They will repeat this for 6 cycles per set, three sets per day, with normal breathing between sets. The third group will practice deep diaphragmatic breathing at a rate of 6-10 breaths per minute for 15 minutes, twice a day. Participants in both the second and third groups are required to follow their assigned breathing programs daily for three consecutive months. At the end of the three months, all participants will be assessed on the same variables measured before the intervention: 1) systolic and diastolic blood pressure levels, 2) blood pressure variability, and 3) inflammation markers, specifically tumor necrosis factor-alpha and interferon-gamma levels in the blood.
- Being tested
- Study 2: deep breathing, Study 2: 4-7-8 breathing, Study 2: slow breathing with device
- Keywords
- Gene, Blood pressure, Breathing
- Medical subject headings
- Genetic Predisposition to Disease, Mouth Breathing, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study 2: deep breathingOther
Participants in the deep breathing group will be randomized to receive a diaphragmatic deep breathing program. They will be instructed to practice deep breathing at a rate of 6-10 breaths per minute for 15 minutes, twice daily, every day for a duration of 3 months.
Study 2: 4-7-8 breathingOther
Participants in the 4-7-8 breathing group will be randomized to receive a 4-7-8 breathing program. They will follow the 4-7-8 breathing training program, which involves inhaling for 4 seconds, holding the breath for 7 seconds, and exhaling for 8 seconds, counted as one cycle. This pattern is to be repeated for 6 cycles to complete one set. They will perform 12 sets per day-6 sets in the morning and 6 sets in the evening-with normal breathing between each set. This routine will be carried out daily for a duration of 3 months.
Study 2: slow breathing with deviceOther
Participants in the slow breathing with device group will be randomized to receive a slow breathing with device. They will undergo deep breathing training using a resistance-based breathing device called BreathMax, set at 25% of their maximal inspiratory pressure. The breathing rate will be 6 breaths per minute, continuously for 15 minutes, twice a day. This routine will be performed daily for a duration of 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Study 2: control group | No intervention | Participants will not receive any breathing training. |
| Study 2: deep breathing | Active comparator | Participants will practice deep diaphragmatic breathing at a rate of 6-10 breaths per minute for 15 minutes, twice a day. Participants are required to follow their assigned breathing programs daily for three consecutive months. Receives: Other: Study 2: deep breathing |
| Study 2: 4-7-8 breathing | Experimental | Participants will practice the 4-7-8 breathing technique, which involves inhaling for 4 seconds, holding the breath for 7 seconds, and exhaling for 8 seconds-this constitutes one cycle. They will repeat this for 6 cycles per set, three sets per day, with normal breathing between sets. Participants are required to follow their assigned breathing programs daily for three consecutive months. Receives: Other: Study 2: 4-7-8 breathing |
| Study 2: slow breathing with device | Active comparator | Participants will practice deep breathing using a resistance-based breathing device called "BreathMax" which provides water pressure resistance set at 25% of their maximum inspiratory capacity. The breathing rate will be set at 6 breaths per minute, continued for 15 minutes per session, twice daily. Participants are required to follow their assigned breathing programs daily for three consecutive months. Receives: Other: Study 2: slow breathing with device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study 1: expression of adrenomedullin (ADM)
Expression of gene adrenomedullin (ADM) in fold unit
Measured: Day 1
Study 1: expression of angiopoietin-like 4 (ANGPTL4)
Expression of gene angiopoietin-like 4 (ANGPTL4) in fold unit
Measured: Day 1
Study 1: expression of proto-oncogene c-Fos (FOS)
Expression of gene proto-oncogene c-Fos (FOS) in fold unit
Measured: Day 1
Study 1: expression of prostaglandin-endoperoxide synthase 2 (PTGS2)
Expression of gene prostaglandin-endoperoxide synthase 2 (PTGS2) in fold unit
Measured: Day 1
Study 1: expression of ubiquitin specific peptidase 8 (USP8)
Expression of gene ubiquitin specific peptidase 8 (USP8) in fold unit
Measured: Day 1
Study 1: tumor necrosis factor-alpha
Marker of inflammation tumor necrosis factor-alpha in picogram/milliliter unit
Measured: Day 1
Study 1: interferon-gamma
Marker of inflammation interferon-gamma in picogram/milliliter unit
Measured: Day 1
Study 2: systolic blood pressure
Systolic blood pressure in millimeter of mercury unit
Measured: Day 1 and Day 85
Study 2: diastolic blood pressure
Diastolic blood pressure in millimeter of mercury unit
Measured: Day 1 and Day 85
Study 2: systolic blood pressure coefficient of variation
Systolic blood pressure coefficient of variation in percentage unit
Measured: Day 1 and Day 85
Study 2: diastolic blood pressure coefficient of variation
Diastolic blood pressure coefficient of variation in percentage unit
Measured: Day 1 and Day 85
Study 2: tumor necrosis factor-alpha
Marker of inflammation tumor necrosis factor-alpha in picogram/milliliter unit
Measured: Day 1 and Day 85
Study 2: interferon-gamma
Marker of inflammation interferon-gamma in picogram/milliliter unit
Measured: Day 1 and Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Oct 2024
- Primary completion31 Mar 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genetic Predisposition to DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study 1 is a cross-sectional study model and study 2 is an experimental study model.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burapha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piyapong Prasertsri, Burapha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018128
- Sponsor's protocol ID
- IRB1-046/2568
- Status last verified
- Oct 2026
- First submitted
- 1 Jun 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Srikaew P, Buddhisa S, Satthakarn S, Prakobkaew N, Padkao T, Boonla O, Prasertsri P. Visceral Adiposity Is Independently Associated with Hypertension in Thai Adults: A Case-Control Study. Int J Environ Res Public Health. 2026 Aug 14;23(8):1057. doi: 10.3390/ijerph23081057.
PubMed 42652372
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Genes Relating Hypertension in Thailand and the Efficacy of 4-7-8 Breathing Control on Reducing Blood Pressure in Individuals With Hypertension
- ClinicalTrials.gov ID
- NCT07018128
- Acronym / sponsor ID
- IRB1-046/2568
- Keywords
- Gene, Blood pressure, Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Burapha UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study consists of two sub-studies. Study 1 investigates gene expression related to the development of hypertension in Thailand, and Study 2 examines the effectiveness of the 4-7-8 breathing technique in reducing blood pressure in individuals with hypertension.
Detailed description
In Study 1, the sample group includes 200 individuals aged 18-59 years, originating from various regions of Thailand but currently residing in the eastern region. Participants may have normal blood pressure, high blood pressure, or have been diagnosed with hypertension. Blood samples from the participants will be analyzed for the following variables: 1) expression of five genes-adrenomedullin (ADM), angiopoietin-like 4 (ANGPTL4), proto-oncogene c-Fos (FOS), prostaglandin-endoperoxide synthase 2 (PTGS2), and ubiquitin specific peptidase 8 (USP8), and 2) markers of inflammation-tumor necrosis factor-alpha and interferon-gamma levels in the blood.
In Study 2, the sample group includes 75 volunteers from Study 1 who are interested in participating. These volunteers will be randomly assigned into three groups of 25 people each. The first group is a control group whose participants will not receive any breathing training. The second group will practice the 4-7-8 breathing technique, which involves inhaling for 4 seconds, holding the breath for 7 seconds, and exhaling for 8 seconds-this constitutes one cycle. They will repeat this for 6 cycles per set, three sets per day, with normal breathing between sets. The third group will practice deep diaphragmatic breathing at a rate of 6-10 breaths per minute for 15 minutes, twice a day. Participants in both the second and third groups are required to follow their assigned breathing programs daily for three consecutive months. At the end of the three months, all participants will be assessed on the same variables measured before the intervention: 1) systolic and diastolic blood pressure levels, 2) blood pressure variability, and 3) inflammation markers, specifically tumor necrosis factor-alpha and interferon-gamma levels in the blood.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Study 1 is a cross-sectional study model and study 2 is an experimental study model.
| Arm | Type | Receives |
|---|---|---|
| Study 2: control group | No intervention | –Participants will not receive any breathing training. |
| Study 2: deep breathing | Active comparator | Other: Study 2: deep breathingParticipants will practice deep diaphragmatic breathing at a rate of 6-10 breaths per minute for 15 minutes, twice a day. Participants are required to follow their assigned breathing programs daily for three consecutive months. |
| Study 2: 4-7-8 breathing | Experimental | Other: Study 2: 4-7-8 breathingParticipants will practice the 4-7-8 breathing technique, which involves inhaling for 4 seconds, holding the breath for 7 seconds, and exhaling for 8 seconds-this constitutes one cycle. They will repeat this for 6 cycles per set, three sets per day, with normal breathing between sets. Participants are required to follow their assigned breathing programs daily for three consecutive months. |
| Study 2: slow breathing with device | Active comparator | Other: Study 2: slow breathing with deviceParticipants will practice deep breathing using a resistance-based breathing device called "BreathMax" which provides water pressure resistance set at 25% of their maximum inspiratory capacity. The breathing rate will be set at 6 breaths per minute, continued for 15 minutes per session, twice daily. Participants are required to follow their assigned breathing programs daily for three consecutive months. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Male or female
- Aged between 18-59 years
- Of Thai ethnicity
- Does not have hypertension, defined as having an SBP below 130 mmHg and a DBP below 85 mmHg, with no prior diagnosis of hypertension and no history of taking antihypertensive medication
- Originally from various regions of Thailand and currently residing in the eastern region
Key exclusion criteria (12 listed)
- Group of individuals with normal blood pressure
- Has heart disease, such as valvular stenosis or regurgitation, coronary artery disease, or heart failure
- Has obesity, defined as having a body mass index (BMI) of 30 kg/m² or higher
- Has a fever or is currently experiencing an infectious disease, such as COVID-19, the flu, or other infections
- Has respiratory diseases, cardiovascular diseases, cerebrovascular disease, kidney disease, cancer, or immune-related conditions such as allergies, autoimmune diseases (e.g., SLE), immunodeficiency, or rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study 2: deep breathingParticipants in the deep breathing group will be randomized to receive a diaphragmatic deep breathing program. They will be instructed to practice deep breathing at a rate of 6-10 breaths per minute for 15 minutes, twice daily, every day for a duration of 3 months. | Other | Study 2: deep breathing |
| Study 2: 4-7-8 breathingParticipants in the 4-7-8 breathing group will be randomized to receive a 4-7-8 breathing program. They will follow the 4-7-8 breathing training program, which involves inhaling for 4 seconds, holding the breath for 7 seconds, and exhaling for 8 seconds, counted as one cycle. This pattern is to be repeated for 6 cycles to complete one set. They will perform 12 sets per day-6 sets in the morning and 6 sets in the evening-with normal breathing between each set. This routine will be carried out daily for a duration of 3 months. | Other | Study 2: 4-7-8 breathing |
| Study 2: slow breathing with deviceParticipants in the slow breathing with device group will be randomized to receive a slow breathing with device. They will undergo deep breathing training using a resistance-based breathing device called BreathMax, set at 25% of their maximal inspiratory pressure. The breathing rate will be 6 breaths per minute, continuously for 15 minutes, twice a day. This routine will be performed daily for a duration of 3 months. | Other | Study 2: slow breathing with device |
Primary outcome
Study 1: expression of adrenomedullin (ADM)
Time frame: Day 1
Expression of gene adrenomedullin (ADM) in fold unit
Study 1: expression of angiopoietin-like 4 (ANGPTL4)
Time frame: Day 1
Expression of gene angiopoietin-like 4 (ANGPTL4) in fold unit
Study 1: expression of proto-oncogene c-Fos (FOS)
Time frame: Day 1
Expression of gene proto-oncogene c-Fos (FOS) in fold unit
Study 1: expression of prostaglandin-endoperoxide synthase 2 (PTGS2)
Time frame: Day 1
Expression of gene prostaglandin-endoperoxide synthase 2 (PTGS2) in fold unit
Study 1: expression of ubiquitin specific peptidase 8 (USP8)
Time frame: Day 1
Expression of gene ubiquitin specific peptidase 8 (USP8) in fold unit
Study 1: tumor necrosis factor-alpha
Time frame: Day 1
Marker of inflammation tumor necrosis factor-alpha in picogram/milliliter unit
Study 1: interferon-gamma
Time frame: Day 1
Marker of inflammation interferon-gamma in picogram/milliliter unit
Study 2: systolic blood pressure
Time frame: Day 1 and Day 85
Systolic blood pressure in millimeter of mercury unit
Study 2: diastolic blood pressure
Time frame: Day 1 and Day 85
Diastolic blood pressure in millimeter of mercury unit
Study 2: systolic blood pressure coefficient of variation
Time frame: Day 1 and Day 85
Systolic blood pressure coefficient of variation in percentage unit
Study 2: diastolic blood pressure coefficient of variation
Time frame: Day 1 and Day 85
Diastolic blood pressure coefficient of variation in percentage unit
Study 2: tumor necrosis factor-alpha
Time frame: Day 1 and Day 85
Marker of inflammation tumor necrosis factor-alpha in picogram/milliliter unit
Study 2: interferon-gamma
Time frame: Day 1 and Day 85
Marker of inflammation interferon-gamma in picogram/milliliter unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 42652372Srikaew P, Buddhisa S, Satthakarn S, Prakobkaew N, Padkao T, Boonla O, Prasertsri P. Visceral Adiposity Is Independently Associated with Hypertension in Thai Adults: A Case-Control Study. Int J Environ Res Public Health. 2026 Aug 14;23(8):1057. doi: 10.3390/ijerph23081057.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study 2: deep breathing, Study 2: 4-7-8 breathing and Study 2: slow breathing with device in people with Genetic Predisposition to Disease and Breathing, Mouth, run by Burapha University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study 1: expression of adrenomedullin (ADM) (time frame: Day 1). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07018128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.