Relationship Between Acoustic Breath Sounds and Spirometry

NCT06039943 | Unknown

• 1 other identifier: RKK7649
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma COPD

Outcome Measures

Primary Outcomes (3)

• Wheeze score (Tw/Ttot%)

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

  Day 1

• FEV1/FVC

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

  Day 1

• FEV1

  Day 1

Study Arms (1)

All participants

EXPERIMENTAL

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

Device: Wheeze measurement

Interventions

Wheeze measurement DEVICE

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

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Birmingham: lead
• Respiri US: collaborator

Study Sites (1)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B75 7RR, United Kingdom

RECRUITING

Study Officials

• Richard Glover

  University Hospitals Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brendan Cooper, PhD

CONTACT

01213713890; Brendan.Cooper@uhb.nhs.uk

Richard Glover

CONTACT

0121 424 7229; richard.glover@uhb.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 15, 2023
• Study Start: March 13, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)