Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524856
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
The Increase of Lung Capacity Using the Lung Master Pulmonary Exerciser
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Increase of Lung Capacity Using the Lung Master Pulmonary Exerciser
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 breathor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None