Набор скоро начнётся NCT07152691

Non-Invasive Swallowing Monitoring Device

— Наблюдательное Dysphagia Swallowing Muscles

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: Dysphagia, Swallowing Muscles. Базовые параметры: 20 лет — 90 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: Тайвань
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

Establishing a Computational Model for a Non-Invasive Swallowing Monitoring Device: A Pilot Study

Обзор

This project aims to develop a non-invasive monitoring approach using wearable devices, with validation against high-resolution impedance manometry. We plan to recruit 20 healthy participants aged 20-50 years and 20 patients with dysphagia. Patients will first undergo swallowing endoscopy to assess their swallowing status. Electromagnetic near-field coupling technology will then be applied to collect muscle contraction data during swallowing. A wearable sensor attached to the neck will provide detailed dynamic data on swallowing muscle activity to support clinical applications. Validation will be performed using high-resolution impedance manometry. In addition, anthropometric measurements, biochemical tests, and swallowing-related questionnaires will be collected. Statistical analysis will be used to examine correlations between measurement modalities and validate the effectiveness of the developed wearable technology.

Подробное описание

As Taiwan enters a super-aged society in 2025, the number of elderly patients with multiple comorbidities is rapidly increasing, and the risk of dysphagia rises with advancing age. Due to neuronal degeneration and muscle atrophy, elderly patients often experience slower recovery of swallowing ability after general anesthesia, sometimes requiring up to seven days to return to baseline function. Therefore, postoperative monitoring of swallowing function and timely rehabilitation interventions are essential to reduce complications and facilitate early discharge. Traditional swallowing assessment methods, such as videofluoroscopic swallowing study and high-resolution manometry, provide valuable information but are limited by radiation exposure and invasiveness. Hence, the development of non-invasive swallowing measurement devices is of great importance.

This project aims to develop a non-invasive monitoring approach using wearable devices, with validation against high-resolution impedance manometry. We plan to recruit 20 healthy participants aged 20-50 years and 20 patients with dysphagia. The patients will first undergo Videofluoroscopic Swallow Study (VFSS) or swallowing endoscopy to assess their swallowing status. Electromagnetic near-field coupling technology will then be applied to collect muscle contraction data during swallowing. A wearable sensor attached to the neck will not only capture heart rate and respiratory rate but also provide detailed dynamic data on swallowing muscle activity to support clinical applications. Validation will be performed using high-resolution impedance manometry. In addition, anthropometric measurements, biochemical tests, and swallowing-related questionnaires will be collected. Statistical analysis will be used to examine correlations between measurement modalities and validate the effectiveness of the developed wearable technology.

This study is expected to provide a breakthrough in swallowing function monitoring and contribute to improving postoperative recovery in elderly patients. Ultimately, it may offer novel strategies for managing dysphagia in an aging society.

Первичные конечные точки

hypopharyngeal mean peak pressure [Срок оценки: 5 minutes]

Критерии участия

Критерии включения

For healthy volunteer groups: (I) Healthy participants aged over 20 years; (II) Body mass index (BMI) between 18.5 and 30.

Inclusion criteria for patients with dysphagia: Penetration-Aspiration Scale (PAS) score > 1 on fiberoptic endoscopic evaluation of swallowing (FEES), and a PAS score > 1 when swallowing two boluses of IDDSI level 0 (thin liquid) consistency. A total of 20 patients was planned for enrollment.