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Relationship Between Acoustic Breath Sounds and Spirometry

Primary Purpose

Asthma COPD

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Wheeze measurement

About this trial

This is an interventional diagnostic trial for Asthma COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University Hospitals Birmingham NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All participants

Arm Description

Participants will undergo wheeze monitoring during tidal breathing prior to spirometry and during a spirometry test.

Outcomes

Primary Outcome Measures

Wheeze score (Tw/Ttot%)

The average proportion of each breath that contained wheeze during a 30 second breath sound recording.

FEV1/FVC

the ratio between forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC)

FEV1

Secondary Outcome Measures

Full Information

NCT ID

NCT06039943

First Posted

September 6, 2023

Last Updated

September 14, 2023

Sponsor

University Hospital Birmingham

Collaborators

Respiri US

1. Study Identification

Unique Protocol Identification Number

NCT06039943

Brief Title

Relationship Between Acoustic Breath Sounds and Spirometry

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 13, 2023 (Actual)

Primary Completion Date

August 1, 2024 (Anticipated)

Study Completion Date

August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital Birmingham

Collaborators

Respiri US

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma COPD

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

All participants

Arm Type

Experimental

Arm Description

Participants will undergo wheeze monitoring during tidal breathing prior to spirometry and during a spirometry test.

Intervention Type

Device

Intervention Name(s)

Wheeze measurement

Intervention Description

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

Primary Outcome Measure Information:

Title

Wheeze score (Tw/Ttot%)

Description

The average proportion of each breath that contained wheeze during a 30 second breath sound recording.

Time Frame

Day 1

Title

FEV1/FVC

Description

the ratio between forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC)

Time Frame

Day 1

Title

FEV1

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brendan Cooper, PhD

Phone

01213713890

Brendan.Cooper@uhb.nhs.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Richard Glover

Phone

0121 424 7229

richard.glover@uhb.nhs.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Glover

Organizational Affiliation

University Hospitals Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Birmingham NHS Foundation Trust

City

Birmingham

State/Province

West Midlands

ZIP/Postal Code

B75 7RR

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Richard Glover

Phone

01214247229

Richard.glover@uhb.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD will not be available to other researchers

Learn more about this trial

Relationship Between Acoustic Breath Sounds and Spirometry

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