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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03492359
Recruitment Status : Completed
First Posted : April 10, 2018
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Pneumacare Ltd
Information provided by (Responsible Party):
Landon Pediatric Foundation

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: Thora-3Di Device: Body Plethysmography Device: Spirometry Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Tidal Breathing Patterns Measured by Thora-3DI™ Structured Light Plethysmography for Evaluation of Severity of Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Active Comparator: Normal Control
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
Device that uses a grid of structured light to measure chest and abdominal wall movement
Other Name: Structured Light Plethysmography

Device: Body Plethysmography
A pulmonary function test (PFT) for measuring total lung volume.

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

Active Comparator: COPD Patients
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
Device that uses a grid of structured light to measure chest and abdominal wall movement
Other Name: Structured Light Plethysmography

Device: Body Plethysmography
A pulmonary function test (PFT) for measuring total lung volume.

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




Primary Outcome Measures :
  1. Difference in SLP Breath Timing indices measured in seconds and between Patients and Healthy Subjects [ Time Frame: Baseline ]
    SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing

  2. Difference in SLP derived Relative Contribution (measured in %) between Patients and Healthy Subjects [ Time Frame: Baseline ]
    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

  3. Difference in SLP derived Phase (measured in degrees) between Patients and Healthy Subjects [ Time Frame: Baseline ]
    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

  4. Difference in SLP derived displacement rate derived parameters (measured in distance per second) between Patients and Healthy Subjects [ Time Frame: Baseline ]
    SLP breathing parameters derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing

  5. Difference in SLP displacement rate derived ratios between Patients and Healthy Subjects (measured in distance per second) between Patients and Healthy Subjects [ Time Frame: Baseline ]
    SLP breathing parameters ratios derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing

  6. Correlation between SLP parameters with lung Function parameters measured by spirometry and body box plethysmography ( FEV1; FEV1/FVC; TLC and RV) [ Time Frame: Baseline ]
    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


Secondary Outcome Measures :
  1. The trends in tidal breathing patterns between varying severities of COPD (based on the GOLD grading system). [ Time Frame: Baseline ]
    The trends in tidal breathing patterns between varying severities of COPD as measured by the GOLD grading system.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492359


Locations
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United States, California
Ventura County Medical Center
Ventura, California, United States, 93003
Sponsors and Collaborators
Landon Pediatric Foundation
Pneumacare Ltd

Publications:
Ghezzi M, Tenero L, Piazza M, Bodini A, Piacentini G. Structured light plethysmography: new method to evaluate expiratory flow limitation in asthmatic children. Eur Respir J. 2015;46(suppl 59):PA3641.
Hmeidi H, Chadwick E, Lenney W, et al. IE50 measured by structured light plethysmography (SLP) can differentiate between children with and without asthma, and can detect response to a bronchodilator. Am J Respir Crit Care Med. 2016;193 Meeting Abstracts:A4505.
Hmeidi H, Chadwick E, Lenney W, et al. Structured light plethysmography (SLP) can quantify abnormal breathing in children aged 2-12 admitted with acute asthma. Am J Respir Crit Care Med. 2016;193 Meeting Abstracts:A4506.
Chen Y, Xin Z, Qin C. Analysis of tidal breathing flow-volume curves in stable COPD patients. Chinese J Prac Intern Med. 2005;11:978-980.
Stick S. Measurements during tidal breathing. In: Stocks J, Sly P, Tepper R, Morgan W, eds. Infant respiratory function testing: Wiley-Liss; 1996:117-138.
de Boer W, Lasenby J, Cameron J, Wareham R, Ahmad S, Roach C et al.SLP:a zero-contact non-invasive method for pulmonary function testing. In: Labrosse F, Zwiggelaar R, Liu Y, Tiddeman B (eds). Proceedings of the British Machine Vision Conference. Aberystwyth: BMVA Press, 2010, 85.1-12. Availble at http://www.bmva.o

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Responsible Party: Landon Pediatric Foundation
ClinicalTrials.gov Identifier: NCT03492359     History of Changes
Other Study ID Numbers: SLP CL1
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Landon Pediatric Foundation:
COPD, Structured Light Plethysmography, COPD severity

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases