DysphagiaNCT07152691
Non-Invasive Swallowing Monitoring Device
An observational study of Dysphagia and Swallowing Muscles, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Swallowing Muscles
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Dec 2025to 31 Dec 2030
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- (I) Current use of any medication that affects gastrointestinal motility;
- (II) History of gastrointestinal surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Taiwan University Hospital
Taipei
Chih-Jun Lai, MD, PhD, +886-965327939, littlecherrytw@gmail.com
Chih-Jun Lai, MD, PhD, littlecherrytw@gmail.com
About this study
Official title: Establishing a Computational Model for a Non-Invasive Swallowing Monitoring Device: A Pilot Study
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.
Read the detailed description
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
- Dysphagia, Swallowing Muscles
- Keywords
- dysphagia, noninvasive monitor, hypophayngeal muscles
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients without dysphagia | patients with dysphagia | |
| patients with dysphagia | patients with dysphagia |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypopharyngeal mean peak pressure
hypopharyngeal muscle contraction
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start15 Dec 2025 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Statistical Center, NTUHCTC, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152691
- Sponsor's protocol ID
- 202504081RINA
- Status last verified
- Dec 2025
- First submitted
- 26 Aug 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to ethical issue
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Computational Model for a Non-Invasive Swallowing Monitoring Device: A Pilot Study
- ClinicalTrials.gov ID
- NCT07152691
- Acronym / sponsor ID
- 202504081RINA
- Conditions
- Dysphagia, Swallowing Muscles
- Keywords
- dysphagia, noninvasive monitor, hypophayngeal muscles
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients without dysphagia | – | –patients with dysphagia |
| patients with dysphagia | – | –patients with dysphagia |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- (I) Current use of any medication that affects gastrointestinal motility;
- (II) History of gastrointestinal surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hypopharyngeal mean peak pressure
Time frame: 5 minutes
hypopharyngeal muscle contraction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No. due to ethical issue
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia and Swallowing Muscles, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chih-Jun Lai, MD, PhD (+886-965327939, littlecherrytw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypopharyngeal mean peak pressure (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.