Thora-3DI™ for Evaluation of Severity of Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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To demonstrate differences in tidal breathing patterns measured by SLP(Structured Light Plethysmography) between healthy subjects and COPD (chronic obstructive pulmonary disease). The correlation between SLP parameters and standard lung function parameters measured by body box and spirometry will also be assessed. Trends in SLP breathing patterns between the different GOLD (Global Initiative for Chronic Obstructive Lung Disease) stages of COPD, and between those and healthy subjects, will be investigated to assess whether SLP can detect differences between groups.

Detailed Description
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Structured light plethysmography (SLP) is a novel, non-contact method for assessing quiet 'tidal' breathing. A number of studies have reported the effects of conditions such as chronic obstructive pulmonary disease (COPD) on tidal breathing patterns, and a previous study has shown that SLP is able to detect differences in ten tidal breathing patterns between healthy subjects and patients with COPD. In this present study, the investigators will aim to confirm the previous findings and also to examine the relationship between SLP tidal breathing parameters and traditional measurements of lung function measured by spirometry and body box plethysmograph. The correlation between SLP parameters with lung Function parameters measured by spirometry and body box plethysmography: forced expiratory volume in one second (FEV1); Forced vital capacity (FVC), FEV1/FVC (forced expiratory volume in one second/forced vital capacity); total lung capacity (TLC) and residual volume (RV). Trends in tidal breathing patterns between varying severities of COPD (based on the (Global initiative for lung disease (GOLD) grading system.

Official Title
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Tidal Breathing Patterns Measured by Thora-3DI™ Structured Light Plethysmography for Evaluation of Severity of Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Thora-3Di
* Device: Body Plethysmography
* Device: Spirometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range 18-80 years, BMI range 18-40 kg/m2 Patients diagnosed, or suspected, with COPD or normal subjects with no previous or current diagnosis of respiratory disease Exclusion Criteria: Patient unable to sit in an upright position for required period of time Patients with significant co morbidities (assessed by the clinician at screening only): Significant unilateral lung disease e.g. pneumonectomy Chest wall or spinal deformity e.g. scoliosis Obstructive sleep apnea (OSA), Apnoea hypopnoea index > 30 (if known) BMI>40 Inability to consent/comply with trial protocol Presence of an acute disease process that might interfere with test performance, e.g. Nausea, vomiting, persistent coughing)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal Control<br>Participants with no diagnosis of respiratory disease between the ages of 0 and 80 whose breathing will be measured using Thora-3Di structured light plethysmography, body plethysmography and spirometry. | Device: Thora-3Di<br>* Device that uses a grid of structured light to measure chest and abdominal wall movement<br>* Other names: Structured Light Plethysmography;Device: Body Plethysmography<br>* A pulmonary function test (PFT) for measuring total lung volume.<br>Device: Spirometry<br>* A pulmonary function tests (PFT) for measuring maximal forced expiratory flow and volume.<br>|
| Active Comparator: COPD Patients<br>Participants with chronic obstructive pulmonary disease between the ages of 0 and 80 whose breathing will be measured using Thora-3Di structured light plethysmography, body plethysmography and spirometry. | Device: Thora-3Di<br>* Device that uses a grid of structured light to measure chest and abdominal wall movement<br>* Other names: Structured Light Plethysmography;Device: Body Plethysmography<br>* A pulmonary function test (PFT) for measuring total lung volume.<br>Device: Spirometry<br>* A pulmonary function tests (PFT) for measuring maximal forced expiratory flow and volume.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in SLP Breath Timing indices measured in seconds and between Patients and Healthy Subjects | SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing | Baseline | 
| Difference in SLP derived Relative Contribution (measured in %) between Patients and Healthy Subjects | SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing that describes the contribution of a region of the thoracoabdominal wall to total displacement | Baseline | 
| Difference in SLP derived Phase (measured in degrees) between Patients and Healthy Subjects | SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing that describes the contribution of a region of the thoracoabdominal wall to total displacement | Baseline | 
| Difference in SLP derived displacement rate derived parameters (measured in distance per second) between Patients and Healthy Subjects | SLP breathing parameters derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing | Baseline | 
| Difference in SLP displacement rate derived ratios between Patients and Healthy Subjects (measured in distance per second) between Patients and Healthy Subjects | SLP breathing parameters ratios derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing | Baseline | 
| Correlation between SLP parameters with lung Function parameters measured by spirometry and body box plethysmography ( FEV1; FEV1/FVC; TLC and RV) | SLP breathing parameters ratios derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing correlated with lung function measured by body plethysmography and spirometry | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The trends in tidal breathing patterns between varying severities of COPD (based on the GOLD grading system). | The trends in tidal breathing patterns between varying severities of COPD as measured by the GOLD grading system. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Structured Light Plethysmography, COPD severity