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Non-Invasive Swallowing Monitoring Device

NCT ID: NCT07152691

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-15

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dysphagia Swallowing Muscles

Keywords

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dysphagia noninvasive monitor hypophayngeal muscles

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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patients without dysphagia

patients with dysphagia

No interventions assigned to this group

patients with dysphagia

patients with dysphagia

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* (I) Current use of any medication that affects gastrointestinal motility;
* (II) History of gastrointestinal surgery.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Statistical Center, NTUHCTC

Attending anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Chih-Jun Lai, MD, PhD

Role: CONTACT

Phone: +886-965327939

Email: [email protected]

Facility Contacts

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Chih-Jun Lai, MD, PhD

Role: primary

Chih-Jun Lai, MD, PhD

Role: backup

Other Identifiers

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202504081RINA

Identifier Type: -

Identifier Source: org_study_id