Relationship Between Acoustic Breath Sounds and Spirometry

Not Applicable

Recruiting

• Conditions: Asthma COPD
• Interventions: Device: Wheeze measurement

• Registration Number: NCT06039943
• Lead Sponsor: University Hospital Birmingham

Brief Summary

The goal of this clinical trial is to assess whether wheeze as assessed by a commercially available wheeze monitor is comparable to lung function as measured during a spirometry test. The main questions it aims to answer are whether measures of airflow obstruction (FEV1, FEV1/FVC, PEF) correlate with wheeze score (Tw/Ttot%).

Participants consenting to take part will undergo wheeze measurement prior to and during a spirometry test and will be asked to complete a series of symptom questionnaires.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-13
• Status Verified: 2023-09
• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-14
• Last Update Submitted: 2023-09-14
• Study First Posted: 2023-09-15
• Last Update Posted: 2023-09-15
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Consenting adult (aged 18-95) University Hospitals Birmingham patient's attending the Lung Function and Sleep Department (LF&S) routinely as part of their standard clinical management pathway for Lung Function testing that includes Spirometry assessments.
• All patients irrespective of condition will be approached to participate.

Exclusion Criteria

• Subjects who are contraindicated to perform spirometry on the day of testing
• Subjects who cannot speak or read English
• Patients accessing non-adult services
• Subjects who are unable or do not wish to consent
• Patients with known or suspected restrictive lung disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	Wheeze measurement	Participants will undergo wheeze monitoring during tidal breathing prior to spirometry and during a spirometry test.

Primary Outcome Measures

Name	Time	Method
FEV1	Day 1
FEV1/FVC	Day 1	the ratio between forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC)
Wheeze score (Tw/Ttot%)	Day 1	The average proportion of each breath that contained wheeze during a 30 second breath sound recording.

Trial Locations

Locations (1)

University Hospitals Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, West Midlands, United Kingdom