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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03492359
Acronym
SLPCOPD
Enrollment
65
Registered
2018-04-10
Start date
2017-05-01
Completion date
2019-01-01
Last updated
2019-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Structured Light Plethysmography, COPD severity

Brief summary

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

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.

Interventions

DEVICEThora-3Di

Device that uses a grid of structured light to measure chest and abdominal wall movement

A pulmonary function test (PFT) for measuring total lung volume.

DEVICESpirometry

A pulmonary function tests (PFT) for measuring maximal forced expiratory flow and volume.

Sponsors

Pneumacare Ltd
CollaboratorINDUSTRY
Landon Pediatric Foundation
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Difference in SLP derived Phase (measured in degrees) between Patients and Healthy SubjectsBaselineSLP 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
Difference in SLP Breath Timing indices measured in seconds and between Patients and Healthy SubjectsBaselineSLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing
Difference in SLP derived Relative Contribution (measured in %) between Patients and Healthy SubjectsBaselineSLP 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
Correlation between SLP parameters with lung Function parameters measured by spirometry and body box plethysmography ( FEV1; FEV1/FVC; TLC and RV)BaselineSLP 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
Difference in SLP derived displacement rate derived parameters (measured in distance per second) between Patients and Healthy SubjectsBaselineSLP breathing parameters derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing
Difference in SLP displacement rate derived ratios between Patients and Healthy Subjects (measured in distance per second) between Patients and Healthy SubjectsBaselineSLP breathing parameters ratios derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing

Secondary

MeasureTime frameDescription
The trends in tidal breathing patterns between varying severities of COPD (based on the GOLD grading system).BaselineThe trends in tidal breathing patterns between varying severities of COPD as measured by the GOLD grading system.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026