ClinicalTrials.gg
RecruitingNCT06450418Updated Sep 10, 2026

Digital App for Speech & Health Monitoring

An observational study in Dementia, Motor Neuron Disease and Multiple Sclerosis, sponsored by University of Edinburgh. Recruiting at 1 site in United Kingdom. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by University of Edinburgh · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
16 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 178 studies in Dementia with a site in United Kingdom — 40 open to participants now, 58 under way, 12 of them phase 3. Dementia · United Kingdom.

Planned enrollment
31st of 54
150 · median 210
Started
2024
with 12 others
Observational
54 of 178
21 open now
Primary completion
2029-01
later than 45 of 57 live
Registered
141st of 178
by date
Lead sponsor
4 of 178
University of Edinburgh

Among the 178 studies in Dementia with a site in United Kingdom, this one is the 31st largest by planned enrollment of the 54 observational ones that give a count, is one of 13 that started in 2024, is one of 54 observational ones, reaches primary completion later than 45 of the 57 other live ones, and was the 141st registered.

Dementia

2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.

Browse Dementia studies →

Open to participants now

40 of the 178 studies in Dementia with a site in United Kingdom are open now. Recruiting first, the newest first:

34 more — sign in →

All 40 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 381 Dementia studies recruiting now, 242 (64%) set no upper age limit and 25 (7%) stop at 75 or younger; 16 take children under 18; 163 take healthy volunteers.

This study: 16 Years and older · all sexes · healthy volunteers too.

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02

Study summary

Many people living with neurodegenerative conditions like dementia, motor neuron disease (MND), multiple sclerosis (MS), and Parkinson's disease (PD), suffer from speech problems. Using common digital technologies such as smartphone apps, the investigators can record and analyse speech in detail to provide new information for people living with these conditions, researchers, and healthcare professionals. This study will investigate the use of these digital speech recordings to help diagnose and monitor these conditions.

To take part, participants will have either a diagnosis of dementia, motor neuron disease, Parkinson's disease or Multiple Sclerosis, OR they will have no diagnosis of a neurological condition. Researchers will compare people with a diagnosis of a Neurological condition to those without.

Read the detailed description

This project aims to create novel speech-based solutions for: 1) Early detection, 2) Monitoring and 3) Stratification of neurodegenerative disorders including dementia, motor neuron disease (MND), Parkinson's disease (PD), and multiple sclerosis(MS). The investigators will develop and validate proof of concept and early-stage algorithms derived from acoustic data, which will be scaled and tested in deeply-phenotyped population.

2.2 Objectives Primary Objectives

  1. To deploy and iterate a digital platform, co-produced with people living with neurodegenerative disorders, for acquisition of speech data from well characterised cohorts of people living with neurodegenerative disorders (dementia, motor neuron disease, multiple sclerosis, Parkinson's disease), and a healthy control cohort (comprising relatives/carers and volunteers without a neurological diagnosis), linked to our highly curated clinical registries at the Anne Rowling Regenerative Neurology Clinic.
  2. To collect a large body of acoustic speech data from well characterised cohorts of people living with neurodegenerative disorders (dementia, MND/ALS, multiple sclerosis, Parkinson's disease), and a healthy control cohort (comprising relatives/carers and volunteers without a neurological diagnosis), linked to highly curated clinical registries.
  3. To apply machine learning approaches directly to acoustic and linguistic signals from voices from people with dementia, MND, MS, Parkinson's, and healthy controls (comprising relatives/carers and volunteers without a neurological diagnosis), and to characterise prosodic patterns (rhythm, intonation, and fluency) without explicit reference to the text which is spoken, providing powerful cues about the health of the speaker.
  4. Compare speech based digital outcome measures to current clinical standards to characterise and validate their clinimetric properties.

Secondary Objectives

  1. Assess the feasibility and acceptability of a digital outcome measure platform in people living with neurodegenerative conditions, for use in clinical care and research.
  2. To create a repository of well characterised acoustic voice samples for open access sharing/collaboration with research and industry partners.
03

Conditions studied

  • Dementia
  • Motor Neuron Disease
  • Multiple Sclerosis
  • Parkinson Disease
04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants with Neurodegenerative Disorders and their relatives or carers without a diagnosis of a Neurodegenerative disorder.

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

  • A person with a diagnosis of Motor Neuron Disease, Dementia, Multiple Sclerosis, or Parkinson's Disease.
  • A relative or carer of the above who does not report to have a neurological condition.
  • A healthy volunteer who does not report to have a neurological condition.

Exclusion criteria

Exclusion Criteria:

  • Age \<16 years
  • Significant and uncorrected visual or hearing impairment (precluding use of the App).
  • Lack capacity to consent to project due to cognitive impairment (precluding understanding of the study and use of the App).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Carers/Realtives/ Healthy - No Diagnosis of a Neurodegenerative Disorder
  • Motor Neuron Disease
  • Multiple Sclerosis
  • Dementia
  • Parkinson's Disease
06

What researchers measure

Primary outcomes

  1. Primary outcome measures

    Area under the curve (AUC) of the receiver operating characteristic (ROC) curve for each of the 4 binary classifiers distinguishing between a disease-positive group and a healthy control group.

    Time frame: 24 months

Secondary outcomes

  1. Secondary outcome measure

    Sensitivity, specificity, positive and negative predictive values for each of the 4 binary classifiers distinguishing between a disease-positive group and a healthy control group.

    Time frame: 24 months

  2. Secondary outcome measure

    Mean squared error of 4 regression models making predictions of condition-specific clinical rating scores (ACE-III, ALSFRS-R, EDSS, MDS-UPDRS)

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Tam J, Weaver C, Ihenacho A, Newton J, Virgo B, Barrett S, Neale J, Perry D, Smith A, Chandran S, Watts O, Pal S; DASH Consortium. Digital App for Speech and Health Monitoring Study (DASH): protocol for a prospective longitudinal case-control observational study for developing speech datasets in neurodegenerative disorders and dementia. BMJ Open. 2025 Dec 5;15(12):e100222. doi: 10.1136/bmjopen-2025-100222. PubMed 41360452 ↗

Individual participant data

Plan to share: No

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 Jul 2024 (actual). Primary completion is estimated for Jan 2029, 54 months after the start.

Of 271 non-industry observational studies under Dementia, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 202. This study's planned 54 months is below that.

Counting every sponsor, half of 293 studies reached it within 67 months; a quarter within 29 and three quarters within 188.

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

Registered
Feb 9, 2024
First posted
Jun 10, 2024
StartActual
Jul 12, 2024
Primary completionEst.
Jan 30, 2029
CompletionEst.
Jun 2029
Last update
Sep 10, 2026
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 Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06450418
Collaborators
NHS Lothian
Responsible party
Sponsor
First posted
Jun 10, 2024
Start date
Jul 12, 2024
Primary completion
Jan 30, 2029 (estimated)
Completion
Jun 2029 (estimated)
Last update
Sep 10, 2026

Study contacts

Christine R Weaver, MSc
Contact
cweaver@ed.ac.uk
01314659512
Suvankar Pal, Prof
principal investigator · University of Edinburgh

Oversight

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

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