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

March 6, 2026 updated by: University of Nebraska

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lung Function in Young and Older Adults
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inspiratory Capacity
Time Frame: baseline and after one month of device use
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
Time Frame: baseline and after one month of device use
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Farahnaz Fallah Tafti, PhD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0108-24-EP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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