Structured Light Plethysmography Against Standard of Care in the Diagnosis and Monitoring of Dysfunctional Breathing

Launched by PNEUMACARE LTD · Jan 31, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new method called Structured Light Plethysmography (SLP) to see how well it can help diagnose and monitor breathing problems, specifically for people who feel breathless without a clear reason. The goal is to compare this new method with the standard care currently used for patients experiencing disproportionate breathlessness. The trial will take place at a single center and will involve measuring breathing patterns over a short period.

To be eligible for this study, participants must be adults who either have controlled breathing issues (but not due to other serious conditions like uncontrolled asthma or heart disease) or are in good respiratory health. Participants will be required to sit upright for the measurements and must not have certain health conditions that could affect their ability to take part. If you join the study, you can expect to undergo breathing tests that will help researchers understand how well SLP works compared to traditional methods. This trial is not yet recruiting, so there will be more details provided once it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • Cohort A: Any adult who is presenting with controlled disproportionate breathlessness will be considered for inclusion as a diseased subject (with excluded comorbidities as cause of breathlessness e.g. uncontrolled asthma (GINA 2019 guidelines), uncontrolled cardiac disease, ILO).
• • Cohort B: Any adult who is in good respiratory health will be considered for inclusion as a normal in the study.
• Exclusion Criteria:
• • Subject unable to sit in an upright position for required period
• * Subjects with significant co morbidities (assessed by the clinician at screening only):
• • Chest wall or spinal deformity e.g. scoliosis OSA, Apnoea hypopnoea index \> 30 (if known)
• • Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participants' ability to participate in the study
• • BMI \> 40
• • Height \> 194 cm
• • Female participant who is pregnant, lactating or planning pregnancy during the course of the study
• • Inability to consent/comply with trial protocol