The Increase of Lung Capacity Using the Lung Master (Pulmonary Exerciser)

NCT06524856 | Recruiting

• 1 other identifier: 0108-24-EP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspnea; Asthma; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Inspiratory Capacity

  After reaching the end of a normal, quiet expiration, the maximum volume of air that can be inspired will be measured.

  baseline and after one month of device use

• Tidal Volume

  The amount of air that moves in or out of the lungs with each respiratory cycle will be measured.

  baseline and after one month of device use

Study Arms (1)

Lung Function in Young and Older Adults

EXPERIMENTAL

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.

Device: Lung Master (Pulmonary Exerciser)

Interventions

Lung Master (Pulmonary Exerciser) DEVICE

During the one-month using the Lung Master at their house, the participant will be using it at least one time every day, either in the morning or in the evening before going to sleep. During the session, the participants will sit upright and try to prolong the inhalation and exhalation breaths through the Lung Master device for at least three seconds. For each session, the participants will try to concentrate on 35-50 breaths in and breaths out which is about 2-5 minutes. Every session can involve using the Pulmonary Exerciser for a minimum of 5 minutes and a maximum of 20 minutes. After each session, participants will be asked to note how long they have used the device and when they have used it. Information from each session will be recorded on the Participant Device Log that will be provided.

Lung Function in Young and Older Adults

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• any respiratory or chronic conditions

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Biomechanics Research Building

Omaha, Nebraska, 68182, United States

RECRUITING

Related Publications (4)

• 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.

  BACKGROUND

• 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.

  PMID: 34610625 BACKGROUND

• David S, Goldin J, Edwards CW. Forced Expiratory Volume. 2024 Oct 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK540970/

  PMID: 31082014 BACKGROUND

• Nguyen JD, Duong H. Pursed-lip Breathing. 2025 Jan 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK545289/

  PMID: 31424873 BACKGROUND

MeSH Terms

Conditions

Dyspnea; Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Farahnaz Fallah Tafti, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Nguyen, BS

CONTACT

402-554-2383; annnguyen@unomaha.edu

Jania Williams, MS

CONTACT

404-895-7610; janiawilliams@unomaha.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 29, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)