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Not Yet RecruitingNCT05713968

Swallowing Evaluation by HRIM in Patients With Cervical Spondylosis

Using High Resolution Impedance Manometry and Videofluoroscopic Measurements of Swallowing Function in Patients Undergoing Cervical Spine Patients

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
National Taiwan University Hospital · Academic / Other
Sex
All
Age
20 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERpatients 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
OTHERpatients 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

Timeline

Start date
2023-01-27
Primary completion
2027-12-31
Completion
2029-12-31
First posted
2023-02-06
Last updated
2023-02-06

Source: ClinicalTrials.gov record NCT05713968. Inclusion in this directory is not an endorsement.