Chronic Obstructive Pulmonary Disease (COPD)SLP-RespDisNCT02626468
Validation of Structured Light Plethysmography - Health and Disease
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Pneumacare Ltd at 1 site in United Kingdom.
Trial summary
Validation of Structured Light Plethysmography (SLP) in patients with conditions such as Chronic Obstructive Pulmonary Disease (COPD) that effect breathing and in healthy participants. Read more about this study
- Who is it for?
- Ages Up to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2013to Sep 2018
- Phase
- Observational
- 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 Up to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A range of diagnostic conditions that effect breathing and healthy normal subjects. The study will aim to recruit: 200 patients from different diagnostic groups between the ages of 0 and 80 100 healthy participants with no diagnosis of respiratory disease, between the ages of 0 and 80
Who may be able to join
- Aged between 0 and 80 years
Who cannot join
- Any contraindication to spirometry (if performed) or a history of a myocardial infarction or chest surgery within 4 weeks
- Patient unable to sit in an upright (or supine in the case of infants) position for required period of time
- Patients with significant co morbidities (assessed by the clinician at screening only):
- Chest wall or spinal deformity e.g. scoliosis
- Obstructive Sleep Apnoea (OSA) 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge University Hospitals Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
Richard Iles, MB, 07736351424, Richard.iles@doctors.org.uk
Richard Iles, MB
About this study
Official title: Validation in Healthy Subjects and Different Diagnostic States
Validation of Structured Light Plethysmography (SLP) in patients with conditions such as Chronic Obstructive Pulmonary Disease (COPD) that effect breathing and in healthy participants.
Read the detailed description
The investigators hypothesize that SLP may be a useful tool to differentiate between different respiratory diseases. To further examine differences in disease and health, and between diseases SLP measurements will be recorded in a range of diagnostic conditions that effect breathing and in healthy normal subjects.
This is a non-randomised observational study to validate Structured Light Plethysmography in two groups of participants: those with Respiratory condition such as COPD and a normal healthy group. Neither group will receive any clinical intervention. SLP data capture and spirometry (as part of the patients clinical care) will be performed by the patients. The data collected from this study will allow examination of different breathing patterns between patients with different diseases, to compare breathing patterns in patients to those in healthy individuals, and to compare breathing patterns within a healthy population.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Normal | Participants with no diagnosis of respiratory disease between the ages of 0 and 80 | |
| COPD | Patients from different diagnostic groups between the ages of 0 and 80 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in SLP Breath Timing indices and 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 Breath Timing Ratios between Patients and Healthy Subjects
SLP breathing parameters derived from the trace of movement over time 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
Secondary outcomes (2)
Forced Expiratory Volume in 1 second (FEV1)
Measurement of FEV1
Measured: Baseline
Forced Vital Capacity (FVC)
Measurement of FVC
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 Dec 2015 (estimated)
- Study startMar 2013
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pneumacare Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626468
- Sponsor's protocol ID
- PMC-T3D-004
- Acronym
- SLP-RespDis
- Status last verified
- Jul 2018
- First submitted
- 3 Dec 2015
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 15994402de 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.
PubMed 6701820
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation in Healthy Subjects and Different Diagnostic States
- ClinicalTrials.gov ID
- NCT02626468
- Acronym / sponsor ID
- SLP-RespDis / PMC-T3D-004
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pneumacare LtdIndustry (pharma, biotech, devices)
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- Mar 2013
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 10 Dec 2015 (estimated)
- 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.
Validation of Structured Light Plethysmography (SLP) in patients with conditions such as Chronic Obstructive Pulmonary Disease (COPD) that effect breathing and in healthy participants.
Detailed description
The investigators hypothesize that SLP may be a useful tool to differentiate between different respiratory diseases. To further examine differences in disease and health, and between diseases SLP measurements will be recorded in a range of diagnostic conditions that effect breathing and in healthy normal subjects.
This is a non-randomised observational study to validate Structured Light Plethysmography in two groups of participants: those with Respiratory condition such as COPD and a normal healthy group. Neither group will receive any clinical intervention. SLP data capture and spirometry (as part of the patients clinical care) will be performed by the patients. The data collected from this study will allow examination of different breathing patterns between patients with different diseases, to compare breathing patterns in patients to those in healthy individuals, and to compare breathing patterns within a healthy population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal | – | –Participants with no diagnosis of respiratory disease between the ages of 0 and 80 |
| COPD | – | –Patients from different diagnostic groups between the ages of 0 and 80 |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A range of diagnostic conditions that effect breathing and healthy normal subjects. The study will aim to recruit: 200 patients from different diagnostic groups between the ages of 0 and 80 100 healthy participants with no diagnosis of respiratory disease, between the ages of 0 and 80
Key inclusion criteria (1 listed)
- Aged between 0 and 80 years
Key exclusion criteria (8 listed)
- Any contraindication to spirometry (if performed) or a history of a myocardial infarction or chest surgery within 4 weeks
- Patient unable to sit in an upright (or supine in the case of infants) position for required period of time
- Patients with significant co morbidities (assessed by the clinician at screening only):
- Chest wall or spinal deformity e.g. scoliosis
- Obstructive Sleep Apnoea (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.
Primary outcome
Difference in SLP Breath Timing indices and 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 Breath Timing Ratios between Patients and Healthy Subjects
Time frame: Baseline
SLP breathing parameters derived from the trace of movement over time 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
2 secondary outcomes
Forced Expiratory Volume in 1 second (FEV1)
Time frame: Baseline
Forced Vital Capacity (FVC)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Background: PubMed 15994402Miller 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.
- Backgroundde 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
- Background: PubMed 6701820Morgan 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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Pneumacare Ltd at 1 site in United Kingdom.
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 1 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: status not confirmed, as of the sponsor's last update on 10 Jul 2018. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Wilson, PhD (01223 967 414, rachel.wilson@pneumacare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in SLP Breath Timing indices and 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 NCT02626468, which also lists 3 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 10 Jul 2018.