Validation of Structured Light Plethysmography - Health and Disease

Study Overview
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Brief Summary
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Validation of Structured Light Plethysmography (SLP) in patients with conditions such as Chronic Obstructive Pulmonary Disease (COPD) that effect breathing and in healthy participants.

Detailed Description
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The investigators hypothesize that SLP may be a useful tool to differentiate between different respiratory diseases. To further examine differences in disease and health, and between diseases SLP measurements will be recorded in a range of diagnostic conditions that effect breathing and in healthy normal subjects. This is a non-randomised observational study to validate Structured Light Plethysmography in two groups of participants: those with Respiratory condition such as COPD and a normal healthy group. Neither group will receive any clinical intervention. SLP data capture and spirometry (as part of the patients clinical care) will be performed by the patients. The data collected from this study will allow examination of different breathing patterns between patients with different diseases, to compare breathing patterns in patients to those in healthy individuals, and to compare breathing patterns within a healthy population.

Official Title
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Validation in Healthy Subjects and Different Diagnostic States

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 0 and 80 years Exclusion Criteria: Any contraindication to spirometry (if performed) or a history of a myocardial infarction or chest surgery within 4 weeks Patient unable to sit in an upright (or supine in the case of infants) position for required period of time Patients with significant co morbidities (assessed by the clinician at screening only): Chest wall or spinal deformity e.g. scoliosis Obstructive Sleep Apnoea (OSA) Apnoea hypopnoea index > 30 (if known) An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in the study BMI > 40 Inability to consent/comply with trial protocol

Ages Eligible for Study
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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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal<br>Participants with no diagnosis of respiratory disease between the ages of 0 and 80 | |
| COPD<br>Patients from different diagnostic groups between the ages of 0 and 80 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in SLP Breath Timing indices and 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 Breath Timing Ratios between Patients and Healthy Subjects | SLP breathing parameters derived from the trace of movement over time 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in 1 second (FEV1) | Measurement of FEV1 | Baseline | 
| Forced Vital Capacity (FVC) | Measurement of FVC | Baseline |