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NCT Number: NCT07152691

Non-Invasive Swallowing Monitoring Device

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.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • (I) Current use of any medication that affects gastrointestinal motility;
  • (II) History of gastrointestinal surgery.

Treatment and study plan

Primary outcomes

  1. hypopharyngeal mean peak pressure

    Time frame: 5 minutes

    hypopharyngeal muscle contraction

Study contacts

Contact information is provided by the study sponsor or research team.

Chih-Jun Lai, MD, PhD

CONTACT

[email protected]

+886-965327939

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Sep 3, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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