Relationship Between Acoustic Breath Sounds and Spirometry

A Comparative Single Centre Study Assessing the Relationship Between Acoustic Breath Sounds as Measured by a Commercially Available Sound Recording Device Against Standard of Care (Spirometry) in the Assessment of Airflow Obstruction in Patients Who Plan to Undergo Spirometry Testing

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06039943

Enrollment

200

Registered

2023-09-15

Start date

2023-03-13

Completion date

2024-08-01

Last updated

2023-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma COPD

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.

Interventions

DEVICEWheeze measurement

Acoustic breath sounds will be measured during tidal breathing prior to spirometry and during a spirometry attempt.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United Kingdom

Contacts

Primary ContactBrendan Cooper, PhD

Brendan.Cooper@uhb.nhs.uk01213713890

Backup ContactRichard Glover

richard.glover@uhb.nhs.uk0121 424 7229

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026