Asthma ChronicNCT04799678
Pilot Voice Sample Collection From People With Asthma
An observational study of Asthma Chronic, run by Thomas Antalffy.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Asthma Chronic
- What is being tested?
- Recording voice samples
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Current user of the Smart Asthma app
Who may be able to join
- Current user of the Smart Asthma app
- Over 18
- Volunteers to participate
- Agrees to terms
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Collecting Anonymous Voice Samples From Users of the Smart Asthma App
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.
Read the detailed 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.
- Conditions
- Asthma Chronic
- Being tested
- Recording voice samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording voice samplesOther
A maximum of 9 voice sample recording session will be carried out on their phones and take less than 2 minutes each
| Study group | Role | What they receive |
|---|---|---|
| Participants | Current user of the Smart Asthma app Receives: Other: Recording voice samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in voice quality
Voice is an effective biomarker to monitor and predict the loss of asthma control
Measured: A maximum of 9 voice sample recording session, 2 minutes each, will be carried out during the 6 months of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Antalffy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Thomas Antalffy, Smart Respiratory Products Ltd.
- Investigators
- Thomas Antalffy, MD, Principal investigator, Managing Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799678
- Sponsor's protocol ID
- VoiceRecPilot
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2021
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collecting Anonymous Voice Samples From Users of the Smart Asthma App
- ClinicalTrials.gov ID
- NCT04799678
- Acronym / sponsor ID
- VoiceRecPilot
- Conditions
- Asthma Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Thomas AntalffyIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: Recording voice samplesCurrent user of the Smart Asthma app |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Current user of the Smart Asthma app
Key inclusion criteria (4 listed)
- Current user of the Smart Asthma app
- Over 18
- Volunteers to participate
- Agrees to terms
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recording voice samplesA maximum of 9 voice sample recording session will be carried out on their phones and take less than 2 minutes each | Other | Participants |
Primary outcome
Changes in voice quality
Time frame: A maximum of 9 voice sample recording session, 2 minutes each, will be carried out during the 6 months of the study
Voice is an effective biomarker to monitor and predict the loss of asthma control
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: No. No plans to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Antalffy, MD principal investigator
Managing Director
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Chronic, run by Thomas Antalffy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Antalffy, MD (+447815690353, thomas@smartrespiratory.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in voice quality (time frame: A maximum of 9 voice sample recording session, 2 minutes each, will be carried out during the 6 months of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.