Validation of Structured Light Plethysmography - Health and Disease

NCT02626468 | Unknown

• 1 other identifier: PMC-T3D-004
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (6)

• 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

• 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

Secondary Outcomes (2)

• Forced Expiratory Volume in 1 second (FEV1)

  Baseline

• Forced Vital Capacity (FVC)

  Baseline

Study Arms (2)

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

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Aged between 0 and 80 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Pneumacare Ltd: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Cambridge University Hospitals Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

Related Publications (3)

• 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.

  PMID: 15994402 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 6701820 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rachel Wilson, PhD

CONTACT

01223 967 414; rachel.wilson@pneumacare.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 10, 2015
• Study Start: March 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)