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NCT04799678 Clinical Trial

Pilot Voice Sample Collection From People With Asthma

Asthma Chronic Clinical Trial

Official title:
Collecting Anonymous Voice Samples From Users of the Smart Asthma App

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04799678
Other study ID # VoiceRecPilot
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date December 1, 2021

Study information
Verified date March 2021
Source Smart Respiratory Products Ltd.
Contact Thomas Antalffy, MD
Phone +447815690353
Email thomas@smartrespiratory.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Human speech is as unique as a fingerprint and analysing speech had advanced so much that speech can now be used instead of PIN numbers in banking. The investigators want to find out whether changes in everyday speech can signal the worsening of asthma. The investigators are planning to collect voice samples from people as their asthma gets better and worse in order to analyse the changes in voice quality - if any. The participants donating the voice samples will remain anonymous and the voice files will be transferred securely to our analytic system.

Description:

Over 18 users of the Smart Asthma app (by Smart Respiratory Products Ltd) will be asked if they wish to participate in the study by recording voice samples. The question will be posed within the app and can be answered with a tap. Those interested in participating will be shown a short plain English description of the goals and methodology of the project before enrolled. A maximum of 9 voice sample recording session will be carried out on the phones of participants and take less than 2 minutes each, so participants will spend a total of fewer than 18 minutes during the entire trial. Sessions will be offered after participants have recorded their asthma symptoms, lung function and inhaler use in the normal course of using the app. Participants may accept or decline each individual offer to record their voice. Participants will have a chance to play each voice recording before sharing it anonymously with the investigators. Participants can discontinue their participation at any time and can ask investigators to delete all their data. The investigators will be analyse collected voice samples for changes in voice quality. The changes in voice quality will be compared against changes in lung function and asthma symptoms to determine what changes in voice quality, if any, are indicative of a change in asthma control.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 75
Est. completion date December 1, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Current user of the Smart Asthma app - Over 18 - Volunteers to participate - Agrees to terms Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Recording voice samples
A maximum of 9 voice sample recording session will be carried out on their phones and take less than 2 minutes each

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Thomas Antalffy

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in voice quality Voice is an effective biomarker to monitor and predict the loss of asthma control A maximum of 9 voice sample recording session, 2 minutes each, will be carried out during the 6 months of the study
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