Relationship Between Acoustic Breath Sounds and Spirometry

Asthma COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06039943
• Other study ID #: RKK7649
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: September 2023
• Source: University Hospital Birmingham
• Contact: Brendan Cooper, PhD
• Phone: 01213713890
• Email: Brendan.Cooper[@]uhb.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma COPD
• Respiratory Sounds

Intervention

Device:
• Wheeze measurement
Acoustic breath sounds will be measured during tidal breathing prior to spirometry and during a spirometry attempt.

Locations

Country	Name	City	State
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Birmingham	Respiri US

Country where clinical trial is conducted

United Kingdom, 

Outcome

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