NCT04255446

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

An Observational, Controlled, Single Centre Study Validating the Structured Light Plethysmography Against Standard of Care in the Diagnosis and Monitoring of Dysfunctional Breathing

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Pneumacare Ltd · Industry
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Cohort A: This study is a pilot study with four study visits (Screening, Baseline, week 13 and week 26) to generate data to characterise the tidal breathing patterns and parameters with Thora3Di™. Subjects will have a screening visit within 0 to 14 days prior to the first study visit. For each study visit, subjects will be seen in the clinical research facility and have two 5-minute SLP measurements (at rest and on exertion). The SLP measurement should be performed prior to standard lung function tests with minimal impact on clinical time and not change to hospital attendance. Also, each visit subjects will be asked to report concomitant medications and adverse events, and fill several questionnaires forms as outlined in the SOAs. Cohort B: Healthy subjects will have only one visit for this study. After signing the informed consent form, subjects will undergo two 5-minutes SLP measurements (at rest and on exertion).

Conditions

• Dysfunctional Breathing

Interventions

Type	Name	Description
DEVICE	Thora3DiTM	Not international

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-08-01
• Completion: 2026-10-01
• First posted: 2020-02-05
• Last updated: 2024-04-03

Locations

1 site across 1 country: United Kingdom