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Completed

NCT Number: NCT02543333

Validation of Structured Light Plethysmography: Asthma

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.

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Key information

Age range

2 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cambridge University Hospitals Foundation Trust, Cambridge, Cambridgeshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change from Baseline in SLP Parameters after Bronchodilator Reversibility Test

    Time frame: Baseline 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.

  2. Difference in SLP Parameters between Asthma Patients and Healthy Subjects

    Time frame: Baseline

    SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing.

Secondary outcomes

  1. Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) after Bronchodilator Reversibility Test

    Time frame: Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)

    Measurement of FEV1 before and after bronchodilator

  2. Change from Baseline in Forced Vital Capacity (FVC) after Bronchodilator Reversibility Test

    Time frame: Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)

    Measurement of FEV1 before and after bronchodilator

Sponsors and collaborators

Lead sponsor

Pneumacare Ltd

Industry

Collaborators

  • Cambridge University Hospitals NHS Foundation Trust
  • Keele University
  • University Hospitals of North Midlands NHS Trust

Registry information

Official study title

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

Acronym: SLPBD

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 7, 2015
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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