- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04799678
Pilot Voice Sample Collection From People With Asthma
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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Current user of the Smart Asthma app
- Over 18
- Volunteers to participate
- Agrees to terms
Exclusion Criteria:
- None
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Participants
Current user of the Smart Asthma app
|
A maximum of 9 voice sample recording session will be carried out on their phones and take less than 2 minutes each
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in voice quality
Tidsramme: 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
|
A maximum of 9 voice sample recording session, 2 minutes each, will be carried out during the 6 months of the study
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Thomas Antalffy, MD, Managing Director
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VoiceRecPilot
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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