Validation of Structured Light Plethysmography - Health and Disease (SLP-RespDis)

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Rachel Wilson, PhD; Phone Number: 01223 967 414; Email: rachel.wilson@pneumacare.com

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Recruiting
      • Cambridge University Hospitals Foundation Trust
      • Contact: Richard Iles, MB; Phone Number: 07736351424; Email: Richard.iles@doctors.org.uk
      • Principal Investigator: Richard Iles, MB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume in 1 second (FEV1)	Measurement of FEV1	Baseline
Forced Vital Capacity (FVC)	Measurement of FVC	Baseline

Collaborators and Investigators

• Sponsor: Pneumacare Ltd
• Collaborators: Cambridge University Hospitals NHS Foundation Trust

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: December 3, 2015
• First Submitted That Met QC Criteria: December 7, 2015
• First Posted (Estimate): December 10, 2015

Study Record Updates

• Last Update Posted (Actual): July 10, 2018
• Last Update Submitted That Met QC Criteria: July 7, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: PMC-T3D-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO