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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thora-3Di
Body Plethysmography
Spirometry
Sponsored by
Landon Pediatric Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Structured Light Plethysmography, COPD severity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Ventura County Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Normal Control

COPD Patients

Arm 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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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
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
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

Secondary Outcome Measures

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.

Full Information

First Posted
July 5, 2017
Last Updated
May 3, 2019
Sponsor
Landon Pediatric Foundation
Collaborators
Pneumacare Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03492359
Brief Title
Thora-3DI™ for Evaluation of Severity of Chronic Obstructive Pulmonary Disease (COPD)
Acronym
SLPCOPD
Official Title
Tidal Breathing Patterns Measured by Thora-3DI™ Structured Light Plethysmography for Evaluation of Severity of Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Landon Pediatric Foundation
Collaborators
Pneumacare Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Structured Light Plethysmography, COPD severity

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Control
Arm Type
Active Comparator
Arm 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.
Arm Title
COPD Patients
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Thora-3Di
Other Intervention Name(s)
Structured Light Plethysmography
Intervention Description
Device that uses a grid of structured light to measure chest and abdominal wall movement
Intervention Type
Device
Intervention Name(s)
Body Plethysmography
Intervention Description
A pulmonary function test (PFT) for measuring total lung volume.
Intervention Type
Device
Intervention Name(s)
Spirometry
Intervention Description
A pulmonary function tests (PFT) for measuring maximal forced expiratory flow and volume.
Primary Outcome Measure Information:
Title
Difference in SLP Breath Timing indices measured in seconds and between Patients and Healthy Subjects
Description
SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing
Time Frame
Baseline
Title
Difference in SLP derived Relative Contribution (measured in %) between Patients and Healthy Subjects
Description
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
Time Frame
Baseline
Title
Difference in SLP derived Phase (measured in degrees) between Patients and Healthy Subjects
Description
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
Time Frame
Baseline
Title
Difference in SLP derived displacement rate derived parameters (measured in distance per second) between Patients and Healthy Subjects
Description
SLP breathing parameters derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing
Time Frame
Baseline
Title
Difference in SLP displacement rate derived ratios between Patients and Healthy Subjects (measured in distance per second) between Patients and Healthy Subjects
Description
SLP breathing parameters ratios derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing
Time Frame
Baseline
Title
Correlation between SLP parameters with lung Function parameters measured by spirometry and body box plethysmography ( FEV1; FEV1/FVC; TLC and RV)
Description
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
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
The trends in tidal breathing patterns between varying severities of COPD (based on the GOLD grading system).
Description
The trends in tidal breathing patterns between varying severities of COPD as measured by the GOLD grading system.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
Ventura County Medical Center
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
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.
Results Reference
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Citation
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.
Results Reference
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Citation
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.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
10658362
Citation
Kostianev S, Hristova A, Iluchev D. Characteristics of tidal expiratory flow pattern in healthy people and patient with chronic obstructive pulmonary disease. Folia Med (Plovdiv). 1999;41(3):18-25.
Results Reference
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PubMed Identifier
9864007
Citation
Williams EM, Madgwick RG, Morris MJ. Tidal expired airflow patterns in adults with airway obstruction. Eur Respir J. 1998 Nov;12(5):1118-23. doi: 10.1183/09031936.98.12051118. Erratum In: Eur Respir J 1999 Jan;13(1):229.
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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.
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PubMed Identifier
28096696
Citation
Motamedi-Fakhr S, Wilson RC, Iles R. Tidal breathing patterns derived from structured light plethysmography in COPD patients compared with healthy subjects. Med Devices (Auckl). 2016 Dec 29;10:1-9. doi: 10.2147/MDER.S119868. eCollection 2017.
Results Reference
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PubMed Identifier
11292110
Citation
Poole KA, Thompson JR, Hallinan HM, Beardsmore CS. Respiratory inductance plethysmography in healthy infants: a comparison of three calibration methods. Eur Respir J. 2000 Dec;16(6):1084-90. doi: 10.1034/j.1399-3003.2000.16f11.x.
Results Reference
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PubMed Identifier
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Citation
Parreira VF, Vieira DS, Myrrha MA, Pessoa IM, Lage SM, Britto RR. Optoelectronic plethysmography: a review of the literature. Rev Bras Fisioter. 2012 Nov-Dec;16(6):439-53. Epub 2012 Nov 27. English, Portuguese.
Results Reference
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Citation
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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Citation
Whitley E, Ball J. Statistics review 4: sample size calculations. Crit Care. 2002 Aug;6(4):335-41. doi: 10.1186/cc1521. Epub 2002 May 10.
Results Reference
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Thora-3DI™ for Evaluation of Severity of Chronic Obstructive Pulmonary Disease (COPD)

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