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Withdrawn
NCT04255446
Structured Light Plethysmography Against Standard of Care in the Diagnosis and Monitoring of Dysfunctional Breathing
Conditions: Dysfunctional Breathing
Sex: All
Ages: 16 Years – 75 Years
Healthy volunteers: Yes
Sponsor: Pneumacare Ltd
Location: Pneuma Care Ltd Ely Cambridgeshire
Summary
This is an observational, controlled, single-centre study to validate the Thora3Di™ against standard practice in patients who are undergoing investigation for disproportionate breathlessness. The core methodology involves capturing of data during a short period of measurement of breathing using SLP.
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
Source: ClinicalTrials.gov (NCT04255446). StuddyBuddy aggregates publicly available trial information.