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Relationship Between Acoustic Breath Sounds and Spirometry

Sponsor
University Hospital Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT06039943
Collaborator
Respiri US (Other)
200
Enrollment
1
Location
1
Arm
16.7
Anticipated Duration (Months)
12
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Wheeze measurement
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Mar 13, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: All participants

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

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

Outcome Measures

Primary Outcome Measures

  1. Wheeze score (Tw/Ttot%) [Day 1]

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

  2. FEV1/FVC [Day 1]

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

  3. FEV1 [Day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals Birmingham NHS Foundation Trust Birmingham West Midlands United Kingdom B75 7RR

Sponsors and Collaborators

  • University Hospital Birmingham
  • Respiri US

Investigators

  • Principal Investigator: Richard Glover, University Hospitals Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Birmingham
ClinicalTrials.gov Identifier:
NCT06039943
Other Study ID Numbers:
  • RKK7649
First Posted:
Sep 15, 2023
Last Update Posted:
Sep 15, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Respiratory Sounds

Study Results

No Results Posted as of Sep 15, 2023