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Идёт набор NCT06450418

Digital App for Speech & Health Monitoring

Наблюдательное Dementia Motor Neuron Disease Multiple Sclerosis Parkinson Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Dementia, Motor Neuron Disease, Multiple Sclerosis, Parkinson Disease. Базовые параметры: от 16 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Digital App for Speech & Health Monitoring in Neurodegenerative Disorders

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Primary outcome measures [Срок оценки: 24 months]
Вторичные конечные точки (2)
  • Secondary outcome measure [Срок оценки: 24 months]
  • Secondary outcome measure [Срок оценки: 24 months]

Критерии участия

Inclusion Criteria - Any one of the following:

  • 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.

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 1 центр
  • NHS Lothian — Edinburgh

Публикации

  • 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-202 PMID 41360452

Идентификаторы

NCT: NCT06450418 · AC24003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗