Chronic Obstructive Pulmonary DiseaseSLPCOPDNCT03492359
Thora-3DI™ for Evaluation of Severity of Chronic Obstructive Pulmonary Disease (COPD)
A study testing Thora-3Di, Body Plethysmography and Spirometry in people with Chronic Obstructive Pulmonary Disease, run by Landon Pediatric Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Thora-3Di, Body Plethysmography and Spirometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Ventura County Medical Center
Ventura, California, 93003
About this study
Official title: Tidal Breathing Patterns Measured by Thora-3DI™ Structured Light Plethysmography for Evaluation of Severity of Chronic Obstructive Pulmonary Disease (COPD)
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Thora-3Di, Body Plethysmography, Spirometry
- Keywords
- COPD, Structured Light Plethysmography, COPD severity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thora-3DiDevice
Also called Structured Light Plethysmography
Device that uses a grid of structured light to measure chest and abdominal wall movement
Body PlethysmographyDevice
A pulmonary function test (PFT) for measuring total lung volume.
SpirometryDevice
A pulmonary function tests (PFT) for measuring maximal forced expiratory flow and volume.
| Study group | Role | What they receive |
|---|---|---|
| Normal Control | Active comparator | 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. Receives: Device: Thora-3Di; Device: Body Plethysmography; Device: Spirometry |
| COPD Patients | Active comparator | 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. Receives: Device: Thora-3Di; Device: Body Plethysmography; Device: Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
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
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 May 2017
- Primary completion1 Oct 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landon Pediatric Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Pneumacare Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492359
- Sponsor's protocol ID
- SLP CL1
- Acronym
- SLPCOPD
- Status last verified
- May 2019
- First submitted
- 5 Jul 2017
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
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.
PubMed 10658362Williams 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.
PubMed 9864007Stick S. Measurements during tidal breathing. In: Stocks J, Sly P, Tepper R, Morgan W, eds. Infant respiratory function testing: Wiley-Liss; 1996:117-138.
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.
PubMed 28096696Poole 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.
PubMed 11292110Parreira 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.
PubMed 23184278de 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
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.
PubMed 12225610
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tidal Breathing Patterns Measured by Thora-3DI™ Structured Light Plethysmography for Evaluation of Severity of Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT03492359
- Acronym / sponsor ID
- SLPCOPD / SLP CL1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Structured Light Plethysmography, COPD severity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Landon Pediatric FoundationUniversity, hospital or other
- Collaborators
- Pneumacare Ltd
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Control | Active comparator | Device: Thora-3Di, Device: Body Plethysmography, Device: SpirometryParticipants 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. |
| COPD Patients | Active comparator | Device: Thora-3Di, Device: Body Plethysmography, Device: SpirometryParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thora-3DiAlso: Structured Light PlethysmographyDevice that uses a grid of structured light to measure chest and abdominal wall movement | Device | COPD Patients, Normal Control |
| Body PlethysmographyA pulmonary function test (PFT) for measuring total lung volume. | Device | COPD Patients, Normal Control |
| SpirometryA pulmonary function tests (PFT) for measuring maximal forced expiratory flow and volume. | Device | COPD Patients, Normal Control |
Primary outcome
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
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
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
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
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
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
1 secondary outcome
The trends in tidal breathing patterns between varying severities of COPD (based on the GOLD grading system).
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- BackgroundGhezzi 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.
- BackgroundHmeidi 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.
- BackgroundHmeidi 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.
- BackgroundChen 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.
- Background: PubMed 10658362Kostianev 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.
- Background: PubMed 9864007Williams 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.
- BackgroundStick S. Measurements during tidal breathing. In: Stocks J, Sly P, Tepper R, Morgan W, eds. Infant respiratory function testing: Wiley-Liss; 1996:117-138.
- Background: PubMed 28096696Motamedi-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.
- Background: PubMed 11292110Poole 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.
- Background: PubMed 23184278Parreira 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.
- Backgroundde 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
- Background: PubMed 12225610Whitley 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thora-3Di, Body Plethysmography and Spirometry in people with Chronic Obstructive Pulmonary Disease, run by Landon Pediatric Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in SLP Breath Timing indices measured in seconds and between Patients and Healthy Subjects (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03492359, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.