Clinical trial NCT02626468: Validation of Structured Light Plethysmography - Health and Disease
Official title: Validation in Healthy Subjects and Different Diagnostic States
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Pneumacare Ltd
Sponsor class: INDUSTRY
Collaborators: name: Cambridge University Hospitals NHS Foundation Trust
First posted: 2015-12-10
Enrollment: 100
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Aged between 0 and 80 years

Exclusion Criteria:

* 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

Primary outcomes:
measure: Difference in SLP Breath Timing indices and measured in seconds and between Patients and Healthy Subjects
timeFrame: Baseline
measure: Difference in SLP Breath Timing Ratios between Patients and Healthy Subjects
timeFrame: Baseline
measure: Difference in SLP derived Relative Contribution (measured in %) between Patients and Healthy Subjects
timeFrame: Baseline
measure: Difference in SLP derived Phase (measured in degrees) between Patients and Healthy Subjects
timeFrame: Baseline
measure: Difference in SLP derived displacement rate derived parameters (measured in distance per second) between Patients and Healthy Subjects
timeFrame: Baseline
measure: Difference in SLP displacement rate derived ratios between Patients and Healthy Subjects (measured in distance per second) between Patients and Healthy Subjects
timeFrame: Baseline
Secondary outcomes:
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: Baseline
measure: Forced Vital Capacity (FVC)
timeFrame: Baseline
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals Foundation Trust
state: Cambridgeshire
Study officials:
References:
citation: 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.
citation: 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
citation: 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.