Structured Light Plethysmography Against Standard of Care in the Diagnosis and Monitoring of Dysfunctional Breathing (SLPDB)

An Observational, Controlled, Single Centre Study Validating the Structured Light Plethysmography Against Standard of Care in the Diagnosis and Monitoring of Dysfunctional Breathing

This is an observational, controlled, single-centre study to validate the Thora3Di™ against standard practice in patients who are undergoing investigation for disproportionate breathlessness. The core methodology involves capturing of data during a short period of measurement of breathing using SLP.

Study Overview

• Status: Not yet recruiting
• Conditions: Dysfunctional Breathing
• Intervention / Treatment: Device: Thora3DiTM

Detailed Description

Cohort A: This study is a pilot study with four study visits (Screening, Baseline, week 13 and week 26) to generate data to characterise the tidal breathing patterns and parameters with Thora3Di™. Subjects will have a screening visit within 0 to 14 days prior to the first study visit. For each study visit, subjects will be seen in the clinical research facility and have two 5-minute SLP measurements (at rest and on exertion). The SLP measurement should be performed prior to standard lung function tests with minimal impact on clinical time and not change to hospital attendance. Also, each visit subjects will be asked to report concomitant medications and adverse events, and fill several questionnaires forms as outlined in the SOAs.

Cohort B: Healthy subjects will have only one visit for this study. After signing the informed consent form, subjects will undergo two 5-minutes SLP measurements (at rest and on exertion).

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Gin Lee; Phone Number: +44 1223 967418; Email: gin.lee@pneumacare.com
• Study Contact Backup: Name: Jenny Harrison; Phone Number: +441772 521452; Email: Jennifer.HARRISON@lthtr.nhs.uk

Study Locations

• United Kingdom
  • Cambridgeshire
    • Ely, Cambridgeshire, United Kingdom, CB7 4EX
      • Pneuma Care Ltd
      • Contact: Henny Harrison; Phone Number: +441772 521452; Email: Jennifer.HARRISON@lthtr.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Cohort A: Any adult who is presenting with controlled disproportionate breathlessness will be considered for inclusion as a diseased subject (with excluded comorbidities as cause of breathlessness e.g. uncontrolled asthma (GINA 2019 guidelines), uncontrolled cardiac disease, ILO).

• Cohort B: Any adult who is in good respiratory health will be considered for inclusion as a normal in the study.

Description

Inclusion Criteria:

• • Cohort A: Any adult who is presenting with controlled disproportionate breathlessness will be considered for inclusion as a diseased subject (with excluded comorbidities as cause of breathlessness e.g. uncontrolled asthma (GINA 2019 guidelines), uncontrolled cardiac disease, ILO).

  • Cohort B: Any adult who is in good respiratory health will be considered for inclusion as a normal in the study.

Exclusion Criteria:

• Subject unable to sit in an upright position for required period

  • Subjects with significant co morbidities (assessed by the clinician at screening only):
  • Chest wall or spinal deformity e.g. scoliosis OSA, Apnoea hypopnoea index > 30 (if known)
  • Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participants' ability to participate in the study
  • BMI > 40
  • Height > 194 cm
  • Female participant who is pregnant, lactating or planning pregnancy during the course of the study
  • Inability to consent/comply with trial protocol

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dysfunctional Breathing; Patients with Dysfunctional breathing age between 16 to 75 will be included.	Device: Thora3DiTM; Not international
Healthy Volunteers; Healthy Volunteers without any respiratory problems age between 16 to 75 will be included.	Device: Thora3DiTM; Not international

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estabilsih expected value and dispersion of Structured Light Phlethysmography in Dysfunctional breathing patients	Measure SLP parameters during the course of the treatment : Baseline, Week 13 and Week 26 at rest and at exertion	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish a relationship between Structured Light Phlethysmography parameters and patient report outcomes addressed.	Compare SLP parameters with patient outcome reports (Nijmegen and St George Respiratory Questionnaires and BPAT and BORG scores during the course of the treatment	26 weeks
Establish different SLP parameters between patients with dysfunctional breathing and healthy subjects.	Compare the differences in SLP parameters between patients with dysfunctional breathing and healthy subjects	26 weeks

Collaborators and Investigators

• Sponsor: Pneumacare Ltd
• Investigators: Principal Investigator: Aashish Vyas, MD, Royal Preston Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: January 24, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: PCL-SLPDB-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No