Validation of Structured Light Plethysmography - Health and Disease

NCT ID: NCT02626468

Last Updated: 2018-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal

Participants with no diagnosis of respiratory disease between the ages of 0 and 80

No interventions assigned to this group

COPD

Patients from different diagnostic groups between the ages of 0 and 80

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

Pneumacare Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cambridge University Hospitals Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Rachel Wilson, PhD

Role: CONTACT

01223 967 414

Facility Contacts

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Richard Iles, MB

Role: primary

07736351424

References

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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.

Reference Type BACKGROUND
PMID: 15994402 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 6701820 (View on PubMed)

Other Identifiers

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PMC-T3D-004

Identifier Type: -

Identifier Source: org_study_id

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