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Validation of Structured Light Plethysmography: Asthma

Validation of Structured Light Plethysmography: Pre- and Post- Bronchodilator Challenge

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02543333
Acronym
SLPBD
Enrollment
183
Registered
2015-09-07
Start date
2013-07-31
Completion date
2016-07-31
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

Asthma

Keywords

Acute Asthma,

Brief summary

Validation of Structured Light Plethysmography (SLP) in patients with asthma, in patients with acute asthma; an observational study in healthy participants and during patients' clinical investigation of broncho-reversibility in the asthma groups.

Detailed description

A non-randomised observational study to validate Structured Light Plethysmography in three groups of participants: those with stable asthma and those with acute asthma, who are undergoing routine clinical investigation of broncho-reversibility using spirometry. We will also observe a normal healthy group who will receive no clinical intervention. SLP data capture and spirometry (as part of the patients clinical care) will be performed before and after a Bronchodilator reversibility test which is part of the patients normal clinical care (except in the normal healthy group where no bronchodilator will be given). The data collected from this study will allow us to examine the effect of bronchodilators on breathing patterns in these patients and also compare breathing patterns in asthma patients to those in healthy individuals. The participant will wear a plain white t-shirt. Alternatively, the measurement can be taken on bare skin or with the participant (if female) wearing a plain material white bra. The participant is asked to sit down on a chair or lie down with their neck in a neutral position and their back as straight as possible in front of the SLP device (Thora-3Di, Pneumacare Ltd). The projector is lined up to project the grid of light over the participant's chest and upper abdomen. and will be instructed to perform a period of 5 minutes of tidal breathing, They will otherwise be asked to remain as still as possible throughout the measurement. During the sequence of breathing, thoracoabdominal wall movements will be captured by the device. participant on completion of their Bronchodilator Challenge within the Lung Function Department or clinic The SLP measurement is repeated on completion of their Bronchodilator reversibility test within the Lung Function Department or clinic.

Interventions

None listed

Sponsors

Cambridge University Hospitals NHS Foundation Trust
CollaboratorOTHER
University Hospitals of North Midlands NHS Trust
CollaboratorOTHER
Keele University
CollaboratorOTHER
Pneumacare Ltd
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Aged between 2 and 80 years

Exclusion criteria

* Patients with significant co morbidities resulting in clinical instability (assessed by the clinician at screening only): * obstructive sleep apnea, 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
Change from Baseline in SLP Parameters after Bronchodilator Reversibility TestBaseline and 15 minutes after bronchodilator reversibility test (in asthma patients)SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing.
Difference in SLP Parameters between Asthma Patients and Healthy SubjectsBaselineSLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing.

Secondary

MeasureTime frameDescription
Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) after Bronchodilator Reversibility TestBaseline and 15 minutes after bronchodilator reversibility test (in asthma patients)Measurement of FEV1 before and after bronchodilator
Change from Baseline in Forced Vital Capacity (FVC) after Bronchodilator Reversibility TestBaseline and 15 minutes after bronchodilator reversibility test (in asthma patients)Measurement of FEV1 before and after bronchodilator

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026