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

NCT04255446 | Not Yet Recruiting DMC

• 1 other identifier: PCL-SLPDB-2020
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysfunctional Breathing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Establish a relationship between Structured Light Phlethysmography parameters and patient report outcomes addressed.

  26 weeks

• Establish different SLP parameters between patients with dysfunctional breathing and healthy subjects.

  26 weeks

Study Arms (2)

Dysfunctional Breathing

Patients with Dysfunctional breathing age between 16 to 75 will be included.

Device: Thora3DiTM

Healthy Volunteers

Healthy Volunteers without any respiratory problems age between 16 to 75 will be included.

Device: Thora3DiTM

Interventions

Thora3DiTM DEVICE

Not international

Dysfunctional Breathing; Healthy Volunteers

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pneumacare Ltd: lead

Study Sites (1)

Pneuma Care Ltd

Ely, Cambridgeshire, CB7 4EX, United Kingdom

Location

Study Officials

• Aashish Vyas, MD

  Royal Preston Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gin Lee

CONTACT

+44 1223 967418; gin.lee@pneumacare.com

Jenny Harrison

CONTACT

+441772 521452; Jennifer.HARRISON@lthtr.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: February 5, 2020
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)