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Validation of Structured Light Plethysmography - Health and Disease

Validation in Healthy Subjects and Different Diagnostic States

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02626468
Acronym
SLP-RespDis
Enrollment
100
Registered
2015-12-10
Start date
2013-03-31
Completion date
2018-09-30
Last updated
2018-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

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.

Interventions

None listed

Sponsors

Cambridge University Hospitals NHS Foundation Trust
CollaboratorOTHER
Pneumacare Ltd
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in SLP displacement rate derived ratios between Patients and Healthy Subjects (measured in distance per second) between Patients and Healthy SubjectsBaselineSLP breathing parameters ratios derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing
Difference in SLP derived Phase (measured in degrees) between Patients and Healthy SubjectsBaselineSLP 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
Difference in SLP derived displacement rate derived parameters (measured in distance per second) between Patients and Healthy SubjectsBaselineSLP breathing parameters derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing
Difference in SLP Breath Timing indices and measured in seconds and between Patients and Healthy SubjectsBaselineSLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing
Difference in SLP Breath Timing Ratios between Patients and Healthy SubjectsBaselineSLP breathing parameters derived from the trace of movement over time of the thoracoabdominal (TA) wall during tidal breathing
Difference in SLP derived Relative Contribution (measured in %) between Patients and Healthy SubjectsBaselineSLP 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

Secondary

MeasureTime frameDescription
Forced Vital Capacity (FVC)BaselineMeasurement of FVC
Forced Expiratory Volume in 1 second (FEV1)BaselineMeasurement of FEV1

Countries

United Kingdom

Contacts

Primary ContactRachel Wilson, PhD
rachel.wilson@pneumacare.com01223 967 414

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026