Electromagnetic High-Frequency Chest Wall Oscillation on Pulmonary Mucus Clearance in Patients With Impaired Self-Expectoration

NCT07347366 | Recruiting

• 1 other identifier: 21-2025-005
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This exploratory study aims to evaluate the efficacy and safety of an electromagnetic high-frequency, low-strain chest wall oscillation device for enhancing pulm

Conditions

Sputum

Keywords

sputum clearance; respiratory symptoms; Pulmonary Mucus Clearance; Electromagnetic High-Frequency Chest Wall Oscillation

Outcome Measures

Primary Outcomes (1)

• BCSS, Breathlessness, Cough, and Sputum Scale

  The Breathlessness, Cough, and Sputum Scale (BCSS) is a patient-reported outcome measure assessing the severity of breathlessness, cough, and sputum. Each symptom is rated by the patient on a numeric scale from 0 (no symptoms) to 4 (severe symptoms). Individual symptom scores and the total score, calculated as the sum of the three items (range 0-12), are used for analysis, with higher scores indicating more severe symptoms.

  Change rate in Breathlessness, Cough, and Sputum Scale (BCSS) scores at 1 week compared with baseline.

Secondary Outcomes (11)

• mMRC (modified Medical Research Council Dyspnea Scale)

  Change rate in modified Medical Research Council (mMRC) dyspnea scores at 1 week compared with baseline for patient symptom assessment.

• St. George's Respiratory Questionnaire (SGRQ)

  Change rate in St. George's Respiratory Questionnaire (SGRQ) scores at 1 week compared with baseline.

• Visual Analog Scale for Dyspnea (VASD)

  Scores at 1 week compared with baseline.

• VAS (Visual Analogue Scale) - Cough

  Scores at 1 week compared with baseline.

• Cough And Sputum Assessment Questionnaire (CASA-Q)

  Scores at 1 week compared with baseline.

Study Arms (3)

Control Group

ACTIVE COMPARATOR

A high-frequency chest wall oscillation device in the form of a vest (Todaki) is used in patients who require clearance of mucus retained in the lungs, providing high-frequency chest wall vibrations to dislodge sputum adherent to the bronchial walls and facilitate removal of secretions.

Device: CAREWAY

Nine-Motor Device Group

EXPERIMENTAL

Description:This bed-type medical device delivers vibrational energy across the chest wall for patients with respiratory conditions. aiding in the clearance of accumulated sputum in the airways and lungs. It incorporates nine electromagnetic high-frequency, low-strain vibration motors to produce distributed vibrational energy, which is applied via the chest wall oscillation plate to multiple lung regions, enhancing comprehensive sputum clearance through multi-point oscillation

Device: EM HFLS CWSE(Nine-Motor)

Single-Motor Device Intervention

EXPERIMENTAL

Description: This bed-type medical device applies vibrational energy to the chest wall of patients with respiratory diseases to facilitate sputum clearance from the airways and lungs. The device employs a single electromagnetic high-frequency, low-strain vibration motor that generates vibrational energy, which transmits through the chest wall oscillation plate directly to the patient's chest, promoting effective mucus mobilization via targeted oscillations.

Device: EM HFLS CWSE(Single-motor)

Interventions

EM HFLS CWSE(Nine-Motor) DEVICE

This bed-type medical device delivers vibrational energy across the chest wall for patients with respiratory conditions aiding in the clearance of accumulated sputum in the airways and lungs. It incorporates nine electromagnetic high-frequency, low-strain vibration motors to produce distributed vibrational energy, which is applied via the chest wall oscillation plate to multiple lung regions, enhancing comprehensive sputum clearance through multi-point oscillation

Nine-Motor Device Group

EM HFLS CWSE(Single-motor) DEVICE

This bed-type medical device applies vibrational energy to the chest wall of patients with respiratory diseases , to facilitate sputum clearance from the airways and lungs. The device employs a single electromagnetic high-frequency, low-strain vibration motor that generates vibrational energy, which transmits through the chest wall oscillation plate directly to the patient's chest, promoting effective mucus mobilization via targeted oscillations.

Single-Motor Device Intervention

CAREWAY DEVICE

CAREWAY , A high-frequency chest wall oscillation device in the form of a vest (Todaki) is used in patients who require clearance of mucus retained in the lungs, providing high-frequency chest wall vibrations to dislodge sputum adherent to the bronchial walls and facilitate removal of secretions.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients who require sputum clearance.
• Patients who present with fever or respiratory symptoms (cough, sputum) and, after confirmation of findings on imaging studies, are judged by the clinician to require sputum clearance.
• Adult patients (≥ 18 years) who have signed the informed consent form, or patients for whom consent has been obtained from a legally authorized representative

You may not qualify if:

• Patients with severe pneumonia requiring intensive care unit (ICU) treatment.
• Patients with major pulmonary diseases other than pneumonia, such as active tuberculosis or lung cancer.
• Patients with severe respiratory failure (PaO₂/FiO₂ ≤ 200 mmHg).
• Patients with hemodynamically unstable cardiovascular disease (myocardial infarction within the past 3 months, or heart failure of NYHA class 3 or higher).
• Patients hospitalized for head and neck trauma whose surgical site has not yet healed.
• Patients with serious cardiac arrhythmias or hemodynamic instability.
• Patients who have had pneumothorax or massive hemoptysis within the past 6 months, or who currently have hemoptysis.
• Patients who have undergone spinal surgery within the past 6 months or who have acute spinal injury.
• Patients with osteoporosis.
• Patients with bronchopleural fistula.
• Pregnant or breastfeeding women.
• Patients diagnosed with cervical disc disease.
• Individuals who have participated in clinical studies two or more times in the same year, or who have participated in another clinical study within the past 6 months (however, patients enrolled in chronic lung disease cohort studies such as asthma or COPD are allowed).
• Individuals who, in the judgment of the principal investigator or sub-investigator, have clinically significant findings that make them unsuitable for participation in this study

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Rehab lab, Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

RECRUITING

MeSH Terms

Conditions

Signs and Symptoms, Respiratory

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jisoo Baik, Doctoral

CONTACT

82+055-360-4159; zisoo@pusan.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 16, 2026
• Study Start: September 23, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

KR (1)