Swallowing Evaluation by HRIM in Patients With Cervical Spondylosis

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05713968
• Collaborator: (none)
• Enrollment: 50
• Anticipated Duration (Months): 83.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Esophageal Sphincter Relaxing Pressure	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

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

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Using High Resolution Impedance Manometry and Videofluoroscopic Measurements of Swallowing Function in Patients Undergoing Cervical Spine Patients
• Anticipated Study Start Date: Jan 27, 2023
• Anticipated Primary Completion Date: Dec 31, 2027
• Anticipated Study Completion Date: Dec 31, 2029

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. upper esophageal sphincter pressure [30 minutes]

   upper esophageal sphincter opening ability questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT05713968
• Other Study ID Numbers: 202211062DIND
• First Posted: Feb 6, 2023
• Last Update Posted: Feb 6, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 6, 2023