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Active, not recruitingNCT05859438INVITEUpdated Mar 30, 2025

INcorporating VoIce AcTivated Communication Aids Into Everyday Communication

An interventional study of Communication aid support in Dysarthria, sponsored by University of Sheffield. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.

Sponsored by University of Sheffield · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 8 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Dysarthria is a speech disorder resulting in speech that is slow, slurred and difficult to understand, limiting a person's opportunities to study, work, and develop relationships.

People with dysarthria often use communication aids to help them to communicate creating spoken messages using a keyboard, touchscreen or joystick. Communication aids can increase independence but are often too slow to keep pace with normal conversation.

Developments in speech recognition technology have led to apps which can learn to recognise a set of words or sounds spoken by the individual with dysarthria, and connect these with a clear spoken output. The investigator's previous research provides some evidence that these voice input communication apps may be faster than traditional communication aids. This study aims to find out who can benefit from this technology, and what support they will need to use it successfully. This information can be used by professionals involved in providing communication aids, and will help the investigators to plan further research into their effectiveness.

This research has two phases:

  1. 20-30 individuals with dysarthria will be asked to use a voice input communication app for 6 months. The investigator's will collect information on whether VocaTempo improves their communication, and helps participants to reach their goals.
  2. Focus groups will be held with professionals involved in providing and supporting people with communication aids, to understand factors affecting their ability to provide the support identified as needed in part 1 of the research.

The investigators have a panel of communication aid users, who are advising and contributing throughout the study, for example, helping the investigators to identify informal support networks to recruit participants from. The investigators will let people know about the findings through support groups used by people with dysarthria, publications read by people involved in providing communication aids, and academic papers and conferences.

02

Conditions studied

  • Dysarthria

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03

In context

Dysarthria

60 studies on the registry are indexed under Dysarthria; 19 are open to participants now.

This study's planned enrollment of 30 is below the median of 39 across 44 interventional studies indexed under Dysarthria.

Browse Dysarthria studies →

Lead sponsor

University of Sheffield is the lead sponsor of 75 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Over 18 years of age
  • Moderately or severely dysarthric (identified using the Frenchay Dysarthria assessment
  • Minimum of 2 distinct vocalisations over which they have voluntary control
  • Able to give and take part in interviews with appropriate communication support (scores level 1-3 on consent support tool)
  • Communicates predominantly in English

Exclusion criteria

Exclusion Criteria:

  • They have significant cognitive impairment and are unable to give on their own behalf or actively take part in interviews (tested using the Consent Support Tool, scoring at level 4), or are unable to use a communication aid.
  • They have no controlled vocalisations.
  • They have dysarthria as a result of a progressive condition
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Other: Communication aid support

Interventions

  • OtherCommunication aid support

    Support to use voice input voice output communication aids

06

What researchers measure

Primary outcomes

  1. Goal Attainment Scale (measuring change between time points of distance from goal)

    Measures attainment of participant defined goals.

    Time frame: Baseline, 3 and 6 months

Secondary outcomes

  1. Pragmatic Profile of Everyday Communication Skills in Adults (measuring change between time points of pragmatic communication)

    Assesses pragmatic language use

    Time frame: Baseline, 3 and 6 months.

Other outcomes

  1. Speed of Communication by measuring time taken to speak out phrase with device - measuring change between timepoints.

    Measuring speed of communicating with communication aid

    Time frame: 3 and 6 months

  2. System Usability Scale (measuring change between time points)

    Questionnaire asking about usability of communication aid

    Time frame: 3 and 6 months

  3. Semi-structured interview

    Conversation to ascertain participants experience

    Time frame: Baseline

  4. Semi-structured interview

    Conversation to ascertain participants experience

    Time frame: 3 months

  5. Semi-structured interview

    Conversation to ascertain participants experience

    Time frame: 6 months

  6. Participant diary (emails between participant and research which will be used as qualitative data).

    Email diary

    Time frame: 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2023 (actual). Primary completion is estimated for Mar 2025, 22 months after the start.

Of 34 interventional studies with no phase under Dysarthria, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 22 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 20, 2023
First posted
May 16, 2023
StartActual
May 31, 2023
Primary completionEst.
Mar 2025
CompletionEst.
Apr 2025
Last update
Mar 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05859438
Lead sponsor
University of Sheffield
Collaborators
Barnsley Hospital NHS Foundation Trust
Responsible party
Sponsor
First posted
May 16, 2023
Start date
May 31, 2023
Primary completion
Mar 2025 (estimated)
Completion
Apr 2025 (estimated)
Last update
Mar 30, 2025

Study contacts

Kate Fryer
principal investigator · University of Sheffield

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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