Swallowing Contraction StrengthNCT06006195
Investigating the Correlations Between Dysphagia Symptoms and Swallowing Muscle Groups by HRPM-I
An observational study of Swallowing Contraction Strength, run by National Taiwan University Hospital.
Trial summary
Investigating the correlation between the dysphagia symptoms and swallowing muscle groups by high resolution pharyngeal manometry with impedance Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Swallowing Contraction Strength
- What is being tested?
- patients with dysphagia symptoms and patients without dysphagia symptoms
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2023to 31 Dec 2030
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients age from 20 to 80 years old without major organ dysfunction
Who may be able to join
- age from 20 to 80 years
Who cannot join
- bleeding tendency
- pregnancy
- heart failure
- chronic kidney disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigating the Correlation Between Dysphagia Symptoms and Swallowing Muscle Groups by High-Resolution Pharyngeal Manometry With Impedance, Along With the Associated Nutritional Assessment
Investigating the correlation between the dysphagia symptoms and swallowing muscle groups by high resolution pharyngeal manometry with impedance
Read the detailed description
Backgrounds: Some patients would experience dysphagia symptoms before the elective surgery. These patients usually do not have a history of head and neck surgery or cerebrovascular diseases. They are common causes of dysphagia. The anesthetics and airway manipulation can exacerbate dysphagia. However, research is limited on the specific weak muscle groups in patients with dysphagia symptoms, as well as on the existence of associated malnutrition.
Aims: The Eating Assessment Tool (EAT-10) questionnaire will be used to assess dysphagia symptoms. A score of ≥4 on the EAT-10 indicates the presence of dysphagia symptoms, while a score of <4 indicates the absence. This study aims to (1) investigate which specific muscle groups are particularly weak in patients with dysphagia symptoms (EAT-10≥4); (2) to examine whether patients with dysphagia symptoms (EAT-10≥4) have poorer nutritional status than patients without dysphagia symptoms (EAT-10<4).
Methods: This is a cross-sectional study. The investigators will recruit patients undergoing elective orthopedic surgery on the lower extremities, with the age range of 18 to 90 years. On the day of admission, patients will be examined by the EAT-10 questionnaire for dysphagia symptoms. High-resolution pharyngeal manometry with impedance will be conducted to measure the functional of swallowing muscles. Additionally, patients will be given the Mini Nutritional Assessment (MNA) questionnaire (a total score of 30 points). The higher scores indicate the better nutritional status. The albumin level will also be collected. The bioelectrical impedance analysis will be used to measure the patients' body composition, specifically skeletal muscle mass.
- Conditions
- Swallowing Contraction Strength
- Being tested
- patients with dysphagia symptoms, patients without dysphagia symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients with dysphagia symptomsOther
patients with dysphagia symptoms examined by high resolution impedance manometry
patients without dysphagia symptomsOther
patients without dysphagia symptoms examined by high resolution impedance manometry
| Study group | Role | What they receive |
|---|---|---|
| patients with dysphagia symptoms | Not described Receives: Other: patients with dysphagia symptoms | |
| patients without dysphagia symptoms | Not described Receives: Other: patients without dysphagia symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
UES peak pressure, mmHg
Measured: 10 to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start28 Aug 2023 (estimated)
- Primary completion31 Dec 2028 (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 Swallowing Contraction StrengthStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006195
- Sponsor's protocol ID
- 202306130RINB
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to ethical problem
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Correlation Between Dysphagia Symptoms and Swallowing Muscle Groups by High-Resolution Pharyngeal Manometry With Impedance, Along With the Associated Nutritional Assessment
- ClinicalTrials.gov ID
- NCT06006195
- Acronym / sponsor ID
- 202306130RINB
- Conditions
- Swallowing Contraction Strength
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 28 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 23 Aug 2023 (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.
Investigating the correlation between the dysphagia symptoms and swallowing muscle groups by high resolution pharyngeal manometry with impedance
Detailed description
Backgrounds: Some patients would experience dysphagia symptoms before the elective surgery. These patients usually do not have a history of head and neck surgery or cerebrovascular diseases. They are common causes of dysphagia. The anesthetics and airway manipulation can exacerbate dysphagia. However, research is limited on the specific weak muscle groups in patients with dysphagia symptoms, as well as on the existence of associated malnutrition.
Aims: The Eating Assessment Tool (EAT-10) questionnaire will be used to assess dysphagia symptoms. A score of ≥4 on the EAT-10 indicates the presence of dysphagia symptoms, while a score of <4 indicates the absence. This study aims to (1) investigate which specific muscle groups are particularly weak in patients with dysphagia symptoms (EAT-10≥4); (2) to examine whether patients with dysphagia symptoms (EAT-10≥4) have poorer nutritional status than patients without dysphagia symptoms (EAT-10<4).
Methods: This is a cross-sectional study. The investigators will recruit patients undergoing elective orthopedic surgery on the lower extremities, with the age range of 18 to 90 years. On the day of admission, patients will be examined by the EAT-10 questionnaire for dysphagia symptoms. High-resolution pharyngeal manometry with impedance will be conducted to measure the functional of swallowing muscles. Additionally, patients will be given the Mini Nutritional Assessment (MNA) questionnaire (a total score of 30 points). The higher scores indicate the better nutritional status. The albumin level will also be collected. The bioelectrical impedance analysis will be used to measure the patients' body composition, specifically skeletal muscle mass.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with dysphagia symptoms | – | Other: patients with dysphagia symptoms |
| patients without dysphagia symptoms | – | Other: patients without dysphagia symptoms |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients age from 20 to 80 years old without major organ dysfunction
Key inclusion criteria (1 listed)
- age from 20 to 80 years
Key exclusion criteria (4 listed)
- bleeding tendency
- pregnancy
- heart failure
- chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients with dysphagia symptomspatients with dysphagia symptoms examined by high resolution impedance manometry | Other | patients with dysphagia symptoms |
| patients without dysphagia symptomspatients without dysphagia symptoms examined by high resolution impedance manometry | Other | patients without dysphagia symptoms |
Primary outcome
UES peak pressure, mmHg
Time frame: 10 to 15 minutes
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 23 Aug 2023.
- Individual participant dataSharing planned: No. due to ethical problem
Related trials for Swallowing Contraction Strength
Not yet recruiting
ERAS Swallowing Rehabilitation in Elder Patients
The Upper Esophageal Sphincter Contraction Strength
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Swallowing Contraction Strength, run by National Taiwan University Hospital.
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 1 inclusion and 4 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 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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-Min Liu, MD (_886-972652224, lewisliu@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UES peak pressure, mmHg (time frame: 10 to 15 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 23 Aug 2023.