Pilot Voice Sample Collection From People With Asthma | NCT04799678

Studies
Pilot Voice Sample Collection From People With Asthma

NCT04799678

Sponsor

Thomas Antalffy

Status

Unknown status

Last Update Posted

Mar 18, 2021Actual

Enrollment

75Estimated

Phase

Not provided

Conditions

Asthma Chronic

Interventions

Recording voice samples

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Estimated

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Dec 1, 2021Estimated

First Submitted Date

Mar 11, 2021

First Submission Date that Met QC Criteria

Mar 11, 2021

First Posted Date

Mar 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2021

Last Update Posted Date

Mar 18, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thomas Antalffy, Managing Director, Smart Respiratory Products Ltd.Sponsor-Investigator

Lead Sponsor

Thomas AntalffyINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants		Current user of the Smart Asthma app	Other: Recording voice samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Recording voice samples	Other	A maximum of 9 voice sample recording session will be carried out on their phones and take less than 2 minutes each	Participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Current user of the Smart Asthma app
Over 18
Volunteers to participate
Agrees to terms

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Current user of the Smart Asthma app

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas Antalffy, MD	Contact	+447815690353		thomas@smartrespiratory.com

Overall Officials

Name	Affiliation	Role
Thomas Antalffy, MD	Managing Director	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

No plans to share IPD

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided