Publication Date: October 2, 2025
A new clinical trial aims to explore the effects of acute inspiratory muscle training (IMT) in male smokers. The study, sponsored by FATMA DİLARA AKAR ÇAMYAR, will focus on determining the effectiveness of two IMT intensities, 30% and 60% of maximum inspiratory pressure (MIP). Currently, the trial is “not yet recruiting.” Clinical and regulatory teams involved in respiratory health and medical devices may find this study highly relevant.
In this article:
- What to Know About the Trial
- Devices Investigated
- Why This Research Matters
- Frequently Asked Questions
- Conclusion
- Disclaimer
- Announcement Link
What to Know About the Trial
The trial, as listed on ClinicalTrials.gov (NCT07200895), addresses a critical question: how do varying intensities of IMT impact inspiratory muscle performance in male smokers? As of the publication date, the study has not begun recruiting participants.
The trial’s target audience includes male smokers—a group particularly vulnerable to respiratory issues such as chronic obstructive pulmonary disease (COPD). The study will employ IMT devices calibrated at two intensity levels: 30% and 60% of maximum inspiratory pressure (MIP).
Devices Investigated
What Are the IMT Intensity Levels?
Participants in the study will use IMT devices designed to provide resistance during inhalation. The trial will compare two resistance levels:
- 30% MIP: A low-intensity option potentially suitable for individuals with reduced respiratory strength.
- 60% MIP: A higher-intensity setting aimed at testing the upper limits of inspiratory muscle performance.
Understanding the performance of these devices under controlled conditions is crucial for validating their clinical efficacy and safety—a key requirement under medical device regulations.
Why This Research Matters
Smoking remains a leading cause of respiratory disease worldwide. Inspiratory muscle weakness is a significant issue that exacerbates conditions such as COPD. This study could contribute valuable insights into tailored therapeutic interventions for male smokers.
By examining acute effects, this research could also inform developers and regulators about the optimal design and performance parameters for IMT devices. Such data serve as a foundation for future, larger-scale studies, which could ultimately lead to improved clinical outcomes.
Frequently Asked Questions
-
Who can participate in this trial?
The trial targets male smokers. Eligibility criteria will be detailed in the final recruitment announcement. -
Why compare two IMT intensity levels?
Comparing 30% MIP and 60% MIP helps determine the effectiveness and safety of different training intensities. -
When will the trial begin?
As of October 2025, recruitment has not started. Updates can be tracked on the ClinicalTrials.gov link provided.
Conclusion
This upcoming investigation into IMT technologies offers the potential to advance our understanding of respiratory health in male smokers. It could also support regulatory bodies in assessing the performance claims for such devices.
Clinical, regulatory, and quality assurance teams should monitor this trial closely for insights relevant to respiratory device assessment and clearance.
Disclaimer
The information provided here is for educational purposes only and should not be considered legal or clinical advice. Always refer to professional guidelines and regulatory requirements.
Announcement Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07200895?term=medical+device