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

NCT07018128 | Recruiting DMC

• 1 other identifier: IRB1-046/2568
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Genetic Predisposition to Disease; Breathing, Mouth

Keywords

Gene; Blood pressure; Breathing

Outcome Measures

Primary Outcomes (13)

• Study 1: expression of adrenomedullin (ADM)

  Expression of gene adrenomedullin (ADM) in fold unit

  Day 1

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

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

  Day 1

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

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

  Day 1

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

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

  Day 1

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

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

  Day 1

• Study 1: tumor necrosis factor-alpha

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

  Day 1

• Study 1: interferon-gamma

  Marker of inflammation interferon-gamma in picogram/milliliter unit

  Day 1

• Study 2: systolic blood pressure

  Systolic blood pressure in millimeter of mercury unit

  Day 1 and Day 85

• Study 2: diastolic blood pressure

  Diastolic blood pressure in millimeter of mercury unit

  Day 1 and Day 85

• Study 2: systolic blood pressure coefficient of variation

  Systolic blood pressure coefficient of variation in percentage unit

  Day 1 and Day 85

• Study 2: diastolic blood pressure coefficient of variation

  Diastolic blood pressure coefficient of variation in percentage unit

  Day 1 and Day 85

• Study 2: tumor necrosis factor-alpha

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

  Day 1 and Day 85

• Study 2: interferon-gamma

  Marker of inflammation interferon-gamma in picogram/milliliter unit

  Day 1 and Day 85

Study Arms (4)

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.

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.

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.

Other: Study 2: slow breathing with device

Interventions

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: deep breathing

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: 4-7-8 breathing

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.

Study 2: slow breathing with device

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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:
• 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

Sponsors & Collaborators

• Burapha University: lead

Study Sites (1)

Faculty of Allied Health Sciences, Burapha University

MueangChonburi, Changwat Chon Buri, 20131, Thailand

RECRUITING

MeSH Terms

Conditions

Genetic Predisposition to Disease; Mouth Breathing; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Piyapong Prasertsri, Ph.D.

CONTACT

6638103166; piyapong@buu.ac.th

Tadsawiya Padkao, Ph.D.

CONTACT

6638103166; tadsawiya@go.buu.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Other than investigators, data collectors, and outcome adjudicators, different researchers were assigned as outcomes assessors and data analysts.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Model Details: Study 1 is a cross-sectional study model and study 2 is an experimental study model.

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: June 12, 2025
• Study Start: October 1, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

TH (1)