Clinical trial NCT06524856: The Increase of Lung Capacity Using the Lung Master (Pulmonary Exerciser)
Official title: The Increase of Lung Capacity Using the Lung Master (Pulmonary Exerciser)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dyspnea
Chronic Obstructive Pulmonary Disease
Asthma
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The Lung Master will force the lung muscle to work more strenuously and gradually build breathing muscles. Therefore, this study will focus on determining how The Lung Master (Pulmonary Exerciser) increases lung capacity in healthy participants, which leads to improved overall lung functioning.
Primary purpose: BASIC_SCIENCE

Brief summary: Investigators are studying how a device called The Lung Master device can help people breathe better. 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 FDA.

The study has two visits approximately one month apart. In the first visit participants will take a spirometry test, particularly forced vital capacity (FVC), to measure volume change in the lungs. Participants will take the investigational device home to use daily, either in the morning or evening. Use will be recorded in a diary. After one month, participants will return for another spirometry test. Each study visit will take about one to two hours to complete.

Detailed description: Shortness of breath,or dyspnea, occurs when the lungs do not receive enough oxygen leading to discomfort when breathing. This occurs in a quarter of individuals seen in an outpatient setting. Several factors can relate to breathlessness, including lung disorders, heart conditions, or stress. Patients with breathlessness often experience physical limitations in their daily activities. Various treatments for dyspnea are available, however, chronic breathlessness syndrome, such as asthma or chronic obstructive pulmonary disease (COPD), still can persist even when treatment is available.

The Lung Master (Pulmonary Exerciser) is a breathing device used for the respiratory treatment and rehabilitation of chronic breathlessness syndrome. The Lung Master increases resistance during inhalation and exhalation, which works to strengthen the respiratory muscle and improve overall lung function. Therefore, this study will focus on determining how the Lung Master increases lung capacity in healthy individuals. The device is considered investigational and has not been approved by the FDA.

Two groups of healthy participants will be sought for the study: ages 19 to 35 and ages 65 and above. Each participant will have two in-office study visits approximately one month apart. Each visit will take around one to two hours to complete. At the visits, a breathing test called a spirometry test will be done. During the one month interim, the study device will be used at home and the use recorded in a diary. The device must be used least once every day, either in the morning or in the evening for 5 to 20 minutes. You will be contacted after two weeks, and then return the device at the second study visit.

Eligibility criteria: Inclusion Criteria:

* able to complete the at home portion of the study daily
* fall within the age ranges: 19-35 and above 65 years old

Exclusion Criteria:

* any respiratory or chronic conditions

Primary outcomes:
measure: Inspiratory Capacity
timeFrame: baseline and after one month of device use
measure: Tidal Volume
timeFrame: baseline and after one month of device use
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Biomechanics Research Building
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Farahnaz Fallah Tafti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berliner D, Schneider N, Welte T, Bauersachs J. The Differential Diagnosis of Dyspnea. Dtsch Arztebl Int. 2016 Dec 9;113(49):834-845. doi: 10.3238/arztebl.2016.0834.
citation: Sandberg J, Olsson M, Ekstrom M. Underlying conditions contributing to breathlessness in the population. Curr Opin Support Palliat Care. 2021 Dec 1;15(4):219-225. doi: 10.1097/SPC.0000000000000568.
citation: David S, Goldin J, Edwards CW. Forced Expiratory Volume. 2024 Oct 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK540970/
citation: Nguyen JD, Duong H. Pursed-lip Breathing. 2025 Jan 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK545289/