Non-Invasive Swallowing Monitoring Device

Sponsor
National Taiwan University Hospital
Study ID
NCT07152691
Status
Not Yet Recruiting

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Conditions

  • Dysphagia
  • Swallowing Muscles

Eligibility Criteria

Sex
ALL
Age
20 Years - 90 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Sep 3, 2025
Start date
Dec 15, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: patients without dysphagia
    patients with dysphagia
  • Arm: patients with dysphagia
    patients with dysphagia

Primary Outcome Measure

hypopharyngeal mean peak pressure [ Time Frame: 5 minutes ]

Central Contacts

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