Relationship Between Acoustic Breath Sounds and Spirometry

NCT ID: NCT06039943

Last Updated: 2023-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-13

Study Completion Date

2024-08-01

Brief Summary

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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

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Conditions

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Asthma COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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All participants

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

Group Type EXPERIMENTAL

Wheeze measurement

Intervention Type DEVICE

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

Interventions

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Wheeze measurement

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Respiri US

UNKNOWN

Sponsor Role collaborator

University Hospital Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Glover

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Birmingham

Locations

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University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Brendan Cooper, PhD

Role: CONTACT

01213713890

Richard Glover

Role: CONTACT

0121 424 7229

Facility Contacts

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Richard Glover

Role: primary

01214247229

Other Identifiers

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RKK7649

Identifier Type: -

Identifier Source: org_study_id

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