Validation of Structured Light Plethysmography - Health and Disease

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— SLP-RespDis  

Official title:

Validation in Healthy Subjects and Different Diagnostic States

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02626468
• Other study ID #: PMC-T3D-004
• Status: Recruiting
• Start date: March 2013
• Est. completion date: September 2018

Study information

• Verified date: July 2018
• Source: Pneumacare Ltd
• Contact: Rachel Wilson, PhD
• Phone: 01223 967 414
• Email: rachel.wilson[@]pneumacare.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals Foundation Trust	Cambridge	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Pneumacare Ltd	Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Primary	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	Baseline
Primary	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	Baseline
Primary	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	Baseline
Primary	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	Baseline
Primary	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	Baseline
Secondary	Forced Expiratory Volume in 1 second (FEV1)	Measurement of FEV1	Baseline
Secondary	Forced Vital Capacity (FVC)	Measurement of FVC	Baseline