Upper Esophageal Sphincter Relaxing PressureNCT05713968
Swallowing Evaluation by HRIM in Patients With Cervical Spondylosis
An observational study of Upper Esophageal Sphincter Relaxing Pressure, run by National Taiwan University Hospital.
Trial summary
patients with cervical spondylolysis may have swallowing or eating difficulty. In this study, we will use high resolution impedance manometry to evaluate these patients' detailed swallowing mechanisms. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Upper Esophageal Sphincter Relaxing Pressure
- What is being tested?
- patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM and patients with EAT-10 lower than 3 or frailty questionnaire lower than 2
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 27 Jan 2023to 31 Dec 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cervical spondylolysis patients with swallowing difficulty feelings could attend this study. The researchers will hope to help these patients to find the dysphagia mechanisms. If they have to receive early swallowing rehabilitation, we could transfer them and give the rehabilitation physicians advices.
Who may be able to join
- patients with cervical spondylosis associated symptoms or expected to undergo cervical spine surgery
- patients with associated swallowing difficulty symptoms
Who cannot join
- major organ dysfunction, such as renal insufficiency or bleeding tendency
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: Using High Resolution Impedance Manometry and Videofluoroscopic Measurements of Swallowing Function in Patients Undergoing Cervical Spine Patients
patients with cervical spondylolysis may have swallowing or eating difficulty. In this study, we will use high resolution impedance manometry to evaluate these patients' detailed swallowing mechanisms.
Read the detailed description
This study will aim to evaluate swallowing function in patients with cervical spondylolysis by using high resolution impedance manometry (HRIM) along with oral frailty and dysphagia questionnaires. Researchers will plan to enroll 50 patients to investigate this issue. The inclusion criteria will be as following:1) age higher or equal to 20 years old; 2) patients with cervical spondylolysis or associated symptoms. The exclusion criteria will be as following: major organ dysfunction, including chronic kidney disease, bleeding tendency. The primary outcome will be the upper esophageal sphincter relaxing pressure. The researchers will hope to find the swallowing dysfunction mechanisms in these patients.
- Being tested
- patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM, patients with EAT-10 lower than 3 or frailty questionnaire lower than 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIMOther
patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM
patients with EAT-10 lower than 3 or frailty questionnaire lower than 2Other
patients with EAT-10 lower than 3 or frailty questionnaire lower than 2 examined by HRIM
| Study group | Role | What they receive |
|---|---|---|
| patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 | patients may have high risk of aspiration Receives: Other: patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM | |
| patients with EAT-10 lower than 3 or frailty questionnaire lower than 2 | patients may have low risk of aspiration Receives: Other: patients with EAT-10 lower than 3 or frailty questionnaire lower than 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper esophageal sphincter pressure
upper esophageal sphincter opening ability questionnaire
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start27 Jan 2023 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Esophageal Sphincter Relaxing PressureStudies 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
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713968
- Sponsor's protocol ID
- 202211062DIND
- Status last verified
- Jan 2023
- First submitted
- 26 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ethical issue
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using High Resolution Impedance Manometry and Videofluoroscopic Measurements of Swallowing Function in Patients Undergoing Cervical Spine Patients
- ClinicalTrials.gov ID
- NCT05713968
- Acronym / sponsor ID
- 202211062DIND
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 27 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Feb 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.
patients with cervical spondylolysis may have swallowing or eating difficulty. In this study, we will use high resolution impedance manometry to evaluate these patients' detailed swallowing mechanisms.
Detailed description
This study will aim to evaluate swallowing function in patients with cervical spondylolysis by using high resolution impedance manometry (HRIM) along with oral frailty and dysphagia questionnaires. Researchers will plan to enroll 50 patients to investigate this issue. The inclusion criteria will be as following:1) age higher or equal to 20 years old; 2) patients with cervical spondylolysis or associated symptoms. The exclusion criteria will be as following: major organ dysfunction, including chronic kidney disease, bleeding tendency. The primary outcome will be the upper esophageal sphincter relaxing pressure. The researchers will hope to find the swallowing dysfunction mechanisms in these patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 | – | Other: patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIMpatients may have high risk of aspiration |
| patients with EAT-10 lower than 3 or frailty questionnaire lower than 2 | – | Other: patients with EAT-10 lower than 3 or frailty questionnaire lower than 2patients may have low risk of aspiration |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cervical spondylolysis patients with swallowing difficulty feelings could attend this study. The researchers will hope to help these patients to find the dysphagia mechanisms. If they have to receive early swallowing rehabilitation, we could transfer them and give the rehabilitation physicians advices.
Key inclusion criteria (2 listed)
- patients with cervical spondylosis associated symptoms or expected to undergo cervical spine surgery
- patients with associated swallowing difficulty symptoms
Key exclusion criteria (1 listed)
- major organ dysfunction, such as renal insufficiency or bleeding tendency
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 EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIMpatients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM | Other | patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 |
| patients with EAT-10 lower than 3 or frailty questionnaire lower than 2patients with EAT-10 lower than 3 or frailty questionnaire lower than 2 examined by HRIM | Other | patients with EAT-10 lower than 3 or frailty questionnaire lower than 2 |
Primary outcome
upper esophageal sphincter pressure
Time frame: 30 minutes
upper esophageal sphincter opening ability questionnaire
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 6 Feb 2023.
- Individual participant dataSharing planned: No. ethical issue
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 Upper Esophageal Sphincter Relaxing Pressure, 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 2 inclusion and 1 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 6 Feb 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-Jun Lai, MD (+886223123456, littlecherrytw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
upper esophageal sphincter pressure (time frame: 30 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 6 Feb 2023.