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NCT Number: NCT07018128

Expression of Genes Relating Hypertension and Efficacy of 4-7-8 Breathing Control on Reducing Blood Pressure

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.

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Key information

Conditions

Genetic Predisposition to Disease Breathing, Mouth Disease Attributes Disease Susceptibility Mouth Breathing Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Allied Health Sciences, Burapha University

MueangChonburi, Changwat Chon Buri, 20131, Thailand

Location status: Recruiting

Location contact

Piyapong Prasertsri, Ph.D.

CONTACT

[email protected]

6638103166

Piyapong Prasertsri, Ph.D.

PRINCIPAL_INVESTIGATOR

Tadsawiya Padkao, Ph.D.

CONTACT

[email protected]

6638103166

Tadsawiya Padkao, Ph.D.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Study 1:

  • Group of individuals with hypertension

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Study 2:

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Study 2: deep breathing

Other

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 breathing

Other

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 device

Other

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.

Primary outcomes

  1. Study 1: expression of adrenomedullin (ADM)

    Time frame: Day 1

    Expression of gene adrenomedullin (ADM) in fold unit

  2. Study 1: expression of angiopoietin-like 4 (ANGPTL4)

    Time frame: Day 1

    Expression of gene angiopoietin-like 4 (ANGPTL4) in fold unit

  3. Study 1: expression of proto-oncogene c-Fos (FOS)

    Time frame: Day 1

    Expression of gene proto-oncogene c-Fos (FOS) in fold unit

  4. Study 1: expression of prostaglandin-endoperoxide synthase 2 (PTGS2)

    Time frame: Day 1

    Expression of gene prostaglandin-endoperoxide synthase 2 (PTGS2) in fold unit

  5. Study 1: expression of ubiquitin specific peptidase 8 (USP8)

    Time frame: Day 1

    Expression of gene ubiquitin specific peptidase 8 (USP8) in fold unit

  6. Study 1: tumor necrosis factor-alpha

    Time frame: Day 1

    Marker of inflammation tumor necrosis factor-alpha in picogram/milliliter unit

  7. Study 1: interferon-gamma

    Time frame: Day 1

    Marker of inflammation interferon-gamma in picogram/milliliter unit

  8. Study 2: systolic blood pressure

    Time frame: Day 1 and Day 85

    Systolic blood pressure in millimeter of mercury unit

  9. Study 2: diastolic blood pressure

    Time frame: Day 1 and Day 85

    Diastolic blood pressure in millimeter of mercury unit

  10. Study 2: systolic blood pressure coefficient of variation

    Time frame: Day 1 and Day 85

    Systolic blood pressure coefficient of variation in percentage unit

  11. Study 2: diastolic blood pressure coefficient of variation

    Time frame: Day 1 and Day 85

    Diastolic blood pressure coefficient of variation in percentage unit

  12. Study 2: tumor necrosis factor-alpha

    Time frame: Day 1 and Day 85

    Marker of inflammation tumor necrosis factor-alpha in picogram/milliliter unit

  13. Study 2: interferon-gamma

    Time frame: Day 1 and Day 85

    Marker of inflammation interferon-gamma in picogram/milliliter unit

Study contacts

Contact information is provided by the study sponsor or research team.

Piyapong Prasertsri, Ph.D.

CONTACT

[email protected]

6638103166

Tadsawiya Padkao, Ph.D.

CONTACT

[email protected]

6638103166

Sponsors and collaborators

Lead sponsor

Burapha University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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