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Набор скоро начнётся NCT06444789

AI-PROGNOSIS - Digital Biomarkers Development Study (dBM-DEV)

— Наблюдательное 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
В протоколе указаны: connected smartwatch.
Кому может быть актуально
Состояния в реестре: Parkinson Disease. Базовые параметры: от 18 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
Франция, Германия, Испания, Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

AI-based Parkinson's Disease Risk Assessment and Prognosis - Digital Biomarkers Development, Validation and Verification Study (AI-PROGNOSIS dBM-DEV Study)

Обзор

dBM-dev study is a multicentre low-intervention research study which concerns REM sleep behaviour disorder (RBD) who is the best predictor for neurodegenerative diseases including Parkinson's disease (PD). RBD can only be confirmed by polysomnography, which is a cumbersome procedure. The main objective of this study is to identify a novel, robust dBM for the detection of RBD using smartwatch-based recordings of passive data.The study is conducted step-wise on two subsequent cohorts referred to as the development cohort and the confirmation cohort.

Подробное описание

The development cohort comprises 30 patients with RBD and 30 matched controls on sex and age with patients RBD.

The confirmation cohort comprises 30 patients with PD. Following a baseline visit comprising standard clinical evaluation and Parkinson questionnaires, participants will undergo daily-life dBM tracking over a duration of 4 weeks for development cohort and 3 months for confirmation cohort. Additionally, PD patients enrolled in the confirmation cohort will receive a polysomnography which permits to verificate if they have a RBD. The investigation is conducted in four European sites.

Вмешательства

  • Устройство connected smartwatch
    The smartwatch is worn by the patient and data are sent automatically to a server that detects if there are signs of RBD.

Первичные конечные точки

  • Incidence of nights in a confirmation cohort in which RBD episodes are indicated by a score (digital biomarker) derived from passive actigraphy and photoplethysmography data captured by a smartwatch [Срок оценки: 4 weeks]
Вторичные конечные точки (3)
  • correlation between a) and b) [Срок оценки: 4 weeks for a) 3 months for b)]
  • Number of camera-based movement assessments acquired by each participant relative to the number of scheduled camera-based movement assessments. [Срок оценки: 4 weeks (for development cohort) and 3 months (for confirmation cohort)]
  • Number of cognitive tasks completed by each participant relative to the number of scheduled cognitive tasks. [Срок оценки: 4 weeks (for development cohort) and 3 months (for confirmation cohort)]

Критерии участия

Inclusion Criteria for development cohort:

Group of RBD patients

  • Diagnosis of RBD (confirmed by polysomnography)
  • Able to use a compatible smartphone with the study app
  • Having a care partner with whom they share their bedroom at night

Group of Healthy matched controls:

  • Healthy volunteers age and sex matched to the enrolled RBD patients.
  • Able to use a compatible smartphone with the study app
  • No history of RBD.

Inclusion Criteria for confirmation cohort

  • Clinical confirmed diagnosis of PD
  • RBD Screening Questionnaire score : 3 - 12 points
  • Absence of dementia
  • Able to use a compatible smartphone with the study app
  • Having a care partner with whom they share their bedroom at night

Exclusion Criteria for all cohorts:

Inability to consent for study procedures as judged by the investigator. Lacking motivation to participate in study procedures as judged by the investigator.

Lack of social security.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Франция · 1 центр
  • Neurology Toulouse Hospital — Toulouse
Германия · 1 центр
  • Klinik und Poliklinik für Neurologie of University Hospital (Regulatory autorization pendi — Dresden
Испания · 1 центр
  • Hospital Ruber Internacional — Madrid
Великобритания · 1 центр
  • King's college of London (Regulatory authorization pending) — London

Идентификаторы

NCT: NCT06444789 · RC31/23/0184 - RC31/24/0031

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗