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

Landon Pediatric Foundation

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: Thora-3Di; Device: Spirometry; Device: Body Plethysmography

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03492359

SLP CL1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Normal Control

Active Comparator group

Description:

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.

Treatment:

Device: Spirometry

Device: Body Plethysmography

Device: Thora-3Di

COPD Patients

Active Comparator group

Description:

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.

Treatment:

Device: Spirometry

Device: Body Plethysmography

Device: Thora-3Di