- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02543333
Validation of Structured Light Plethysmography: Asthma (SLPBD)
Validation of Structured Light Plethysmography: Pre- and Post- Bronchodilator Challenge
Study Overview
Status
Conditions
Detailed Description
A non-randomised observational study to validate Structured Light Plethysmography in three groups of participants: those with stable asthma and those with acute asthma, who are undergoing routine clinical investigation of broncho-reversibility using spirometry. We will also observe a normal healthy group who will receive no clinical intervention. SLP data capture and spirometry (as part of the patients clinical care) will be performed before and after a Bronchodilator reversibility test which is part of the patients normal clinical care (except in the normal healthy group where no bronchodilator will be given). The data collected from this study will allow us to examine the effect of bronchodilators on breathing patterns in these patients and also compare breathing patterns in asthma patients to those in healthy individuals.
The participant will wear a plain white t-shirt. Alternatively, the measurement can be taken on bare skin or with the participant (if female) wearing a plain material white bra. The participant is asked to sit down on a chair or lie down with their neck in a neutral position and their back as straight as possible in front of the SLP device (Thora-3Di, Pneumacare Ltd). The projector is lined up to project the grid of light over the participant's chest and upper abdomen. and will be instructed to perform a period of 5 minutes of tidal breathing, They will otherwise be asked to remain as still as possible throughout the measurement. During the sequence of breathing, thoracoabdominal wall movements will be captured by the device.
participant on completion of their Bronchodilator Challenge within the Lung Function Department or clinic
The SLP measurement is repeated on completion of their Bronchodilator reversibility test within the Lung Function Department or clinic.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
- Cambridge University Hospitals Foundation Trust
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Staffordshire
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Stoke on Trent, Staffordshire, United Kingdom, ST4 6QG
- Royal Stoke University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
100 participants between the ages of 2 and 80 with stable asthma who are undergoing routine clinical investigation of broncho-reversibilty.
100 participants between the ages of 2 and 80 with acute asthma who are undergoing routine clinical investigation of broncho-reversibilty.
100 participants between the ages of 2 and 80 with no history of respiratory disease ('Normal'). These participants will not undergo a bronchodilator challenge.
Description
Inclusion Criteria:
- Aged between 2 and 80 years
Exclusion Criteria:
- Patients with significant co morbidities resulting in clinical instability (assessed by the clinician at screening only):
- obstructive sleep apnea, Apnoea hypopnoea index > 30 (if known)
- An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in the study
- BMI > 40
- Inability to consent/comply with trial protocol
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Asthma
Patients attending outpatient clinic as part of their clinical care who have FEV1 less than 80% of predicted and are referred by their clinician for a bronchodilator test
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Acute Asthma
Inpatients admitted for an acute asthma exacerbation
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Normal
Participants with no current or previous diagnosis of a respiratory condition
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in SLP Parameters after Bronchodilator Reversibility Test
Time Frame: Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
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SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing.
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Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
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Difference in SLP Parameters between Asthma Patients and Healthy Subjects
Time Frame: Baseline
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SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) after Bronchodilator Reversibility Test
Time Frame: Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
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Measurement of FEV1 before and after bronchodilator
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Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
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Change from Baseline in Forced Vital Capacity (FVC) after Bronchodilator Reversibility Test
Time Frame: Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
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Measurement of FEV1 before and after bronchodilator
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Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard Iles, MD, Cambridge University Hospitals Trust
Publications and helpful links
General Publications
- Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. General considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. doi: 10.1183/09031936.05.00034505. No abstract available.
- de Boer WH, Lasenby J, Cameron J, Wareham R, Ahmad S, Roach C, Hills W, Iles R. 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. BMVA Press, 2010; pp 85.1-85.12
- Morgan MD, Gourlay AR, Denison DM. An optical method of studying the shape and movement of the chest wall in recumbent patients. Thorax. 1984 Feb;39(2):101-6. doi: 10.1136/thx.39.2.101.
- Hmeidi H, Motamedi-Fakhr S, Chadwick EK, Gilchrist FJ, Lenney W, Iles R, Wilson RC, Alexander J. Tidal breathing parameters measured by structured light plethysmography in children aged 2-12 years recovering from acute asthma/wheeze compared with healthy children. Physiol Rep. 2018 Jun;6(12):e13752. doi: 10.14814/phy2.13752.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PMC-T3D-002/2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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