Swallowing Evaluation by HRIM in Patients With Cervical Spondylosis

February 3, 2023 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • patients with cervical spondylosis associated symptoms or expected to undergo cervical spine surgery
  • patients with associated swallowing difficulty symptoms

Exclusion Criteria:

  • major organ dysfunction, such as renal insufficiency or bleeding tendency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with EAT-10 higher than 3 or frailty questionnaire higher than 2
patients may have high risk of aspiration
Other: patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM
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
Other: patients with EAT-10 lower than 3 or frailty questionnaire lower than 2
patients with EAT-10 lower than 3 or frailty questionnaire lower than 2 examined by HRIM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
upper esophageal sphincter pressure
Time Frame: 30 minutes
upper esophageal sphincter opening ability questionnaire
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 27, 2023

Primary Completion (ANTICIPATED)

December 31, 2027

Study Completion (ANTICIPATED)

December 31, 2029

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

February 3, 2023

First Posted (ACTUAL)

February 6, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 202211062DIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

ethical issue

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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