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Starting soon Observational

Non-Invasive Swallowing Monitoring Device

NCT07152691 · tracked via the Priya Life Science Taiwan tracker
Phase
Observational
Started
2025-12-15
Last updated
2025-12-19

Condition(s) studied

DysphagiaSwallowing Muscles

Study summary

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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
90 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • hypopharyngeal mean peak pressure — 5 minutes
    hypopharyngeal muscle contraction

Trial sites (1)

FacilityCityRegionStatus
National Taiwan University Hospital Taipei Taiwan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07152691 on ClinicalTrials.gov ↗ ← All trials in Taiwan