SputumNCT07347366
Electromagnetic High-Frequency Chest Wall Oscillation on Pulmonary Mucus Clearance in Patients With Impaired Self-Expectoration
A study testing CAREWAY, EM HFLS CWSE(Nine-Motor) and EM HFLS CWSE(Single-motor) in people with Sputum, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sputum
- What is being tested?
- CAREWAY, EM HFLS CWSE(Nine-Motor) and EM HFLS CWSE(Single-motor)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Rehab lab, Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
About this study
Official title: Effects of Electromagnetic High-Frequency Chest Wall Oscillation on Pulmonary Mucus Clearance in Patients With Impaired Self-Expectoration: An Investigator-Initiated, Single-Center, Prospective, Exploratory Study
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
- Being tested
- CAREWAY, EM HFLS CWSE(Nine-Motor), EM HFLS CWSE(Single-motor)
- Keywords
- sputum clearance, respiratory symptoms, Pulmonary Mucus Clearance, Electromagnetic High-Frequency Chest Wall Oscillation
- Medical subject headings
- Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAREWAYDevice
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.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Device: EM HFLS CWSE(Single-motor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The modified Medical Research Council (mMRC) Dyspnea Scale is a patient-reported measure assessing the degree of breathlessness during daily activities. Dyspnea severity is rated on a 5-point ordinal scale ranging from 0 (breathlessness only with strenuous exercise) to 4 (too breathless to leave the house or breathless when dressing or undressing). Higher scores indicate more severe dyspnea.
Measured: 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)
The St. George's Respiratory Questionnaire (SGRQ) is a validated patient-reported outcome measure assessing health-related quality of life in patients with respiratory disease. It consists of three domains: Symptoms, Activity, and Impacts. Domain scores and the total score range from 0 to 100, with higher scores indicating worse health status and greater impairment of respiratory-related quality of life.
Measured: Change rate in St. George's Respiratory Questionnaire (SGRQ) scores at 1 week compared with baseline.
Visual Analog Scale for Dyspnea (VASD)
It is a subjective assessment scale in which patients rate their perceived "difficulty in breathing" from 0 (none) to 10 (worst), and it is used to objectively assess changes in symptoms and evaluate treatment effects in patients with respiratory or cardiac diseases
Measured: Scores at 1 week compared with baseline.
VAS (Visual Analogue Scale) - Cough
The severity of cough (VAS) is assessed using a Visual Analogue Scale, a subjective method in which patients rate the severity of their cough by marking their symptoms on a straight line from 0 (no cough at all) to 10 (the worst imaginable), which is then recorded as a score.
Measured: Scores at 1 week compared with baseline.
Cough And Sputum Assessment Questionnaire (CASA-Q)
Cough and sputum were assessed using the Cough and Sputum Assessment Questionnaire (CASA-Q), which evaluates symptom severity and impact across four domains. Domain scores range from 0 to 100, with higher scores indicating less severe symptoms and lower disease impact.
Measured: Scores at 1 week compared with baseline.
Oxygen saturation (SpO2)
Oxygen saturation measured by pulse oximetry, defined as the percentage of hemoglobin saturated with oxygen in arterial blood. Values are expressed as a percentage (%), with higher values indicating better oxygenation status.
Measured: Data at 1 week compared with baseline.
Forced Vital Capacity (FVC)
Forced vital capacity measured using pulmonary function testing, defined as the maximum volume of air forcibly exhaled after full inspiration. Values are recorded in liters (L).
Measured: Data at 1 week compared with baseline.
Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in one second measured using pulmonary function testing, defined as the volume of air forcibly exhaled in the first second of a forced expiration. Values are recorded in liters (L).
Measured: Data at 1 week compared with baseline.
FEV1/FVC Ratio
The ratio of forced expiratory volume in one second to forced vital capacity measured using pulmonary function testing. Values are expressed as a percentage (%).
Measured: Data at 1 week compared with baseline.
Forced Expiratory Flow 25-75% (FEF 25-75)
Forced expiratory flow between 25% and 75% of forced vital capacity measured using pulmonary function testing, reflecting airflow in the mid-portion of forced expiration. Values are recorded in liters per second (L/s).
Measured: Data at 1 week compared with baseline.
Peak Expiratory Flow (PEF)
Peak expiratory flow measured using pulmonary function testing, defined as the maximum flow achieved during a forced expiration. Values are recorded in liters per minute (L/min).
Measured: Data at 1 week compared with baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start23 Sep 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SputumStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong-il Shin, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347366
- Sponsor's protocol ID
- 21-2025-005
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electromagnetic High-Frequency Chest Wall Oscillation on Pulmonary Mucus Clearance in Patients With Impaired Self-Expectoration: An Investigator-Initiated, Single-Center, Prospective, Exploratory Study
- ClinicalTrials.gov ID
- NCT07347366
- Acronym / sponsor ID
- 21-2025-005
- Conditions
- Sputum
- Keywords
- sputum clearance, respiratory symptoms, Pulmonary Mucus Clearance, Electromagnetic High-Frequency Chest Wall Oscillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jan 2026 (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 exploratory study aims to evaluate the efficacy and safety of an electromagnetic high-frequency, low-strain chest wall oscillation device for enhancing pulm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: CAREWAYA 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. |
| Nine-Motor Device Group | Experimental | Device: EM HFLS CWSE(Nine-Motor)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 |
| Single-Motor Device Intervention | Experimental | Device: EM HFLS CWSE(Single-motor)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| CAREWAYCAREWAY , 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 | Control Group |
| EM HFLS CWSE(Nine-Motor)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 | Nine-Motor Device Group |
| EM HFLS CWSE(Single-motor)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 | Single-Motor Device Intervention |
Primary outcome
BCSS, Breathlessness, Cough, and Sputum Scale
Time frame: Change rate in Breathlessness, Cough, and Sputum Scale (BCSS) scores at 1 week compared with baseline.
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.
11 secondary outcomes
mMRC (modified Medical Research Council Dyspnea Scale)
Time frame: 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)
Time frame: Change rate in St. George's Respiratory Questionnaire (SGRQ) scores at 1 week compared with baseline.
Visual Analog Scale for Dyspnea (VASD)
Time frame: Scores at 1 week compared with baseline.
VAS (Visual Analogue Scale) - Cough
Time frame: Scores at 1 week compared with baseline.
Cough And Sputum Assessment Questionnaire (CASA-Q)
Time frame: Scores at 1 week compared with baseline.
Oxygen saturation (SpO2)
Time frame: Data at 1 week compared with baseline.
Forced Vital Capacity (FVC)
Time frame: Data at 1 week compared with baseline.
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Data at 1 week compared with baseline.
FEV1/FVC Ratio
Time frame: Data at 1 week compared with baseline.
Forced Expiratory Flow 25-75% (FEF 25-75)
Time frame: Data at 1 week compared with baseline.
Peak Expiratory Flow (PEF)
Time frame: Data at 1 week compared with baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAREWAY, EM HFLS CWSE(Nine-Motor) and EM HFLS CWSE(Single-motor) in people with Sputum, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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 3 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 16 Jan 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jisoo Baik, Doctoral (82+055-360-4159, zisoo@pusan.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCSS, Breathlessness, Cough, and Sputum Scale (time frame: Change rate in Breathlessness, Cough, and Sputum Scale (BCSS) scores at 1 week compared with baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2026.