Swallowing Evaluation by HRIM in Patients With Cervical Spondylosis

Not yet recruiting

• Conditions: Upper Esophageal Sphincter Relaxing Pressure
• Interventions: Other: patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM; Other: patients with EAT-10 lower than 3 or frailty questionnaire lower than 2

• Registration Number: NCT05713968
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-26
• Study Start: 2023-01-27
• Study First Submitted QC: 2023-02-03
• Last Update Submitted: 2023-02-03
• Study First Posted: 2023-02-06
• Last Update Posted: 2023-02-06
• Primary Completion: 2027-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with EAT-10 higher than 3 or frailty questionnaire higher than 2	patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM	patients may have high risk of aspiration
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	patients may have low risk of aspiration

Primary Outcome Measures

Name	Time	Method
upper esophageal sphincter pressure	30 minutes	upper esophageal sphincter opening ability questionnaire