Lung Master Device for Lung Conditions

Overseen By Jania Williams, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Respiratory, chronic conditions

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a device called The Lung Master can improve breathing by increasing lung capacity. Participants will use the device daily at home for about a month to assess its effectiveness. The trial seeks young adults (19-35 years old) and older adults (over 65) without respiratory or chronic conditions who can commit to the daily routine.

As an unphased trial, participants can contribute to innovative research that could enhance breathing for many.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial excludes people with respiratory or chronic conditions, it's possible that medication use might be a factor. Please consult with the trial coordinators for more details.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial excludes people with respiratory or chronic conditions, it might imply that participants should not be on medications for such conditions.

What prior data suggests that the Lung Master device is safe for improving lung function?

Research shows that the Lung Master device helps improve breathing by increasing lung capacity. It strengthens breathing muscles by adding resistance during inhalation and exhalation. So far, studies have not identified any serious side effects from its use.

Although the FDA has not yet approved the device, similar devices for lung exercises have proven safe. This trial is in an early stage, focusing on the device's function and safety. No severe problems have been reported. Participants in past studies have used it without major issues.

In summary, while the Lung Master is still under evaluation, early findings suggest it is safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Lung Master device is unique because it focuses on improving lung function across different age groups using a non-invasive approach. Unlike traditional treatments that might rely on medications or invasive procedures, this device offers a potentially safer and more accessible way to enhance lung performance. Researchers are excited about its ability to assess and potentially improve lung function in both young adults and older individuals, which could lead to better tailored interventions for maintaining lung health as we age.

What evidence suggests that the Lung Master device is effective for improving lung function?

Research has shown that the Lung Master device, used by participants in this trial, can improve lung capacity, which is crucial for better breathing. Studies suggest that devices like this can enhance lung function by increasing lung air capacity. One study found that breathing exercises, similar to those offered by the Lung Master, improved lung function in individuals with chronic breathing issues. Overall, these findings indicate that the Lung Master might enhance breathing by increasing lung capacity. ^{1 4 5 6 7}

Who Is on the Research Team?

Farahnaz Fallah Tafti, PhD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for individuals with breathing difficulties due to conditions like Asthma or COPD. Participants should be able to attend two study visits one month apart and use the Lung Master device daily, recording their usage in a diary.

Inclusion Criteria

I am either between 19-35 years old or older than 65.

I can do daily study tasks at home.

Exclusion Criteria

I have a history of lung or chronic diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Lung Master device daily at home for one month, with use recorded in a diary. Spirometry tests are conducted at the beginning and end of the treatment period.

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lung Master

Trial Overview The trial is testing the Lung Master, an investigational device designed to increase lung capacity. It involves initial and follow-up spirometry tests one month apart to measure changes in lung volume after daily use of the device.

How Is the Trial Designed?

Group I: Lung Function in Young and Older Adults Experimental Treatment 1 Intervention

Lung functions will be assess for two groups: young and older adults. The age range of 19 to 35 is categorized as young adulthood. This age range was selected because the lungs mature around 19-25 years old. The age range above 65 is designated as late adulthood, where lung function gradually declines.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Published Research Related to This Trial

Patients with lung diseases like COPD can significantly improve their quality of life and longevity by staying active, especially when using portable oxygen systems.

Oxygen conserving devices have evolved to be much lighter and more portable, allowing patients to exercise more effectively, which enhances the physiological benefits of their activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxygen conserving devices and methodologies. Tiep, B., Carter, R.[2008]

Pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD) significantly improves symptoms like shortness of breath (dyspnea), exercise capacity, and overall quality of life, as well as reducing healthcare resource use.

The effectiveness of exercise training during rehabilitation can be enhanced by using bronchodilators, supplemental oxygen, and noninvasive ventilatory support, allowing patients to train at higher intensities for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The roles of bronchodilators, supplemental oxygen, and ventilatory assistance in the pulmonary rehabilitation of patients with chronic obstructive pulmonary disease. ZuWallack, RL.[2008]

A simple prototype device for training respiratory muscles showed significant improvements in lung function and quality of life in 30 COPD patients after 6 weeks of training, similar to standard training methods.

Both the prototype and standard training methods effectively reduced dyspnea scores over time, indicating that the device can be a viable clinical option for enhancing respiratory muscle strength and overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a simple prototype respiratory muscle trainer on respiratory muscle strength, quality of life and dyspnea, and oxidative stress in COPD patients: a preliminary study. Leelarungrayub, J., Pinkaew, D., Puntumetakul, R., et al.[2022]

The treadmill exercise test effectively assesses exercise performance in patients with chronic lung diseases (CLD), particularly in those with chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD), by correlating maximal exercise stages with maximal oxygen uptake.

The test revealed that ventilatory limitations primarily affect COPD patients, while gas exchange and oxygen transport are more critical for ILD patients, highlighting the importance of tailored therapeutic approaches based on the specific limitations identified during exercise testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise performance and limiting factors in patients with chronic lung diseases. Kurihara, N., Fujimoto, S., Terakawa, K., et al.[2008]

In a 4-week study involving 66 adults with COPD, the new Jet spacer device for administering beclomethasone dipropionate showed better improvements in lung function and symptoms compared to a standard actuator, with significant differences in forced expiratory volume and bronchial noises.

The Jet spacer was also reported to be easier to use and resulted in fewer local adverse reactions, highlighting its potential as a more effective delivery method for inhaled corticosteroids in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhaled beclomethasone dipropionate administered through a new spacer device: a controlled clinical study. Vecchiet, L., Pieralisi, G., Ambrosi, L., et al.[2013]

In a study involving patients with COPD and asthma, those using the ELLIPTA inhaler made significantly fewer critical errors in inhaler technique compared to other devices like DISKUS, MDI, and Turbuhaler, indicating better usability.

A majority of patients (57-70%) using ELLIPTA did not require additional instruction for proper use, while higher percentages of patients using other inhalers needed guidance, suggesting that ELLIPTA may enhance medication delivery and patient adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised open-label cross-over study of inhaler errors, preference and time to achieve correct inhaler use in patients with COPD or asthma: comparison of ELLIPTA with other inhaler devices. van der Palen, J., Thomas, M., Chrystyn, H., et al.[2022]

Pulmonary rehabilitation is an effective management strategy for patients with chronic obstructive pulmonary disease (COPD) and other chronic lung diseases, focusing on a multidisciplinary approach that addresses physical, emotional, and social health aspects.

Evidence shows that pulmonary rehabilitation improves symptoms, exercise tolerance, and quality of life while also reducing healthcare resource utilization, making it a valuable component of disease management plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation and COPD. Ries, AL.[2007]

Continued supervised maintenance exercise programs after pulmonary rehabilitation significantly reduce the risk of respiratory-cause hospital admissions in COPD patients, with a risk ratio of 0.62 based on data from 790 participants across eight trials.

While the evidence suggests a trend towards reduced exacerbations and mortality rates with supervised exercise, these outcomes did not reach statistical significance, indicating a need for further high-quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of supervised maintenance exercise following pulmonary rehabilitation on health care use: a systematic review and meta-analysis. Jenkins, AR., Gowler, H., Curtis, F., et al.[2018]

In a study involving 259 adults with asthma and 278 with COPD, 96% of asthma patients and 93% of COPD patients found the placebo dry powder inhaler easy to use, demonstrating high usability and correct operation after 28 days of use.

Adverse events were relatively low, with only 12% of asthma and 15% of COPD subjects reporting any side effects, primarily headaches, indicating that the inhaler is safe for use in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correct use and ease of use of a placebo dry powder inhaler in subjects with asthma and chronic obstructive pulmonary disease. Feldman, GJ., Galkin, DV., Patel, P., et al.[2023]

Traditional outpatient pulmonary rehabilitation significantly improves symptoms like dyspnea, exercise capacity, and quality of life in stable COPD patients, and starting it during or after hospitalization can further enhance these outcomes and potentially reduce healthcare costs and mortality.

Home-based pulmonary rehabilitation is a safe and effective alternative that can increase access to care, but further research is needed to determine its impact on healthcare utilization and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

There's no place like home: Integrating pulmonary rehabilitation into the home setting. Macrea, M., ZuWallack, R., Nici, L.[2019]

In a study involving 19 patients with chronic obstructive pulmonary disease (COPD) and 6 healthy volunteers, patients experienced consistent underventilation and oxygen desaturation during a maximal ventilatory stress test, unlike healthy individuals.

After three weeks of training with an inspiratory resistive device, there was no significant improvement in test performance for patients, and those who showed some improvement still experienced further desaturation, indicating limited efficacy of the training method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in clinical practice. Physiologic conditioning or habituation to suffocation? Jederlinic, P., Muspratt, JA., Miller, MJ.[2019]

The prototype disposable OPEP device, UL-OPEP, was found to be safe for use in patients with COPD over a 1-month period, with no adverse events or negative impacts on lung function, exercise tolerance, or quality of life reported.

User feedback on the UL-OPEP device was generally positive, indicating a favorable user experience, although further research with larger and longer studies is needed to assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An initial evaluation of the safety of a disposable oscillating positive expiratory pressure device in patients with chronic obstructive pulmonary disease: a sort-term pilot study. O'Sullivan, KJ., Power, V., Linnane, B., et al.[2022]

In a study involving 59 subjects with COPD and interstitial lung disease, two oxygen-conserving devices (pulse demand oxygen delivery and pendant reservoir cannula) were found to be similarly effective as standard continuous flow nasal cannula in correcting exercise-induced hypoxemia, with 79% of COPD and 81% of ILD subjects achieving adequate oxygen saturation.

However, the pulse demand oxygen delivery system performed significantly worse in ILD patients, correcting hypoxemia in only 61% of cases, highlighting the need for personalized oxygen flow adjustments for optimal treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are oxygen-conserving devices effective for correcting exercise hypoxemia? Martí, S., Pajares, V., Morante, F., et al.[2016]

Inhaler device errors are prevalent among patients with asthma and COPD, with overall error rates ranging from 50-100% and critical error rates between 14-92%, indicating a significant issue that can affect drug effectiveness.

The review highlights a lack of standardized checklists for assessing inhaler use, suggesting that developing these tools is essential for improving research consistency and understanding the clinical implications of inhaler misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device errors in asthma and COPD: systematic literature review and meta-analysis. Chrystyn, H., van der Palen, J., Sharma, R., et al.[2018]

A 24-week pulmonary rehabilitation program significantly improved exercise capacity, muscle strength, and reduced dyspnea in patients with restrictive lung diseases, with 29 out of 31 patients completing the initial 12 weeks.

Patients showed clinically significant improvements in their 6-minute walk distance and quality of life measures after both 12 and 24 weeks, indicating that pulmonary rehabilitation is effective for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of pulmonary rehabilitation in patients with restrictive lung diseases. Salhi, B., Troosters, T., Behaegel, M., et al.[2018]

Citations

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The Increase of Lung Capacity Using the Lung Master ... The Lung Master (Pulmonary Exerciser) is a breathing device used for the respiratory treatment and rehabilitation of chronic breathlessness ...

2. smartpatients.com smartpatients.com/trials/NCT06524856

The Increase of Lung Capacity Using the Lung Master ... The investigational device increases the amount of air our lungs can hold, which is important for overall lung health. The Lung Master is not approved by the ...

3. digitalcommons.unomaha.edu digitalcommons.unomaha.edu/srcaf/2024/PosterPresentations/84/

The increase of lung capacity using the Lung Master ... This study focuses on determining how the pulmonary exerciser improves lung capacity in healthy individuals, enhancing overall lung functioning.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11320241/

Systematic review and meta-analysis of breathing ... This study indicates that breathing exercises significantly improve postoperative pulmonary function and QoL in lung cancer patients.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1877065723000635

Effect of different exercise programs on lung function in ... According to our results, pulmonary rehabilitation programs could improve FEV1, FEV1%, and FVC, resulting in less air trapping, better respiratory function, and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28663340/

Safety of pulmonary function testing: data from 20 years Conclusion: Routine and specialised PFT is safe for patients, in the context of established screening preparticipation guidelines. In the event ...

7. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT06524856

Lung Master (Pulmonary Exerciser) in Chronic Obstructive ... The Lung Master increases resistance during inhalation and exhalation, which works to strengthen the respiratory muscle and improve overall lung function.