Non-Invasive Swallowing Monitoring Device

NCT07152691 | Not Yet Recruiting

• 1 other identifier: 202504081RINA
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysphagia; Swallowing Muscles

Keywords

dysphagia; noninvasive monitor; hypophayngeal muscles

Outcome Measures

Primary Outcomes (1)

• hypopharyngeal mean peak pressure

  hypopharyngeal muscle contraction

  5 minutes

Study Arms (2)

patients without dysphagia

patients with dysphagia

patients with dysphagia

patients with dysphagia

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers will have no symptoms of dysphagia, whereas patients with dysphagia will undergo fiberoptic endoscopic evaluation of swallowing, with a Penetration-Aspiration Scale (PAS) score greater than 1.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Chih-Jun Lai, MD, PhD

CONTACT

+886-965327939; littlecherrytw@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending anesthesiologist

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)