Swallowing Evaluation by HRIM in Patients With Cervical Spondylosis

NCT ID: NCT05713968

Last Updated: 2023-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-27

Study Completion Date

2029-12-31

Brief Summary

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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

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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

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Upper Esophageal Sphincter Relaxing Pressure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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patients with EAT-10 higher than 3 or frailty questionnaire higher than 2

patients may have high risk of aspiration

patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM

Intervention Type 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

patients with EAT-10 lower than 3 or frailty questionnaire lower than 2

Intervention Type OTHER

patients with EAT-10 lower than 3 or frailty questionnaire lower than 2 examined by HRIM

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Chih-Jun Lai, MD

Role: CONTACT

+886223123456

Other Identifiers

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202211062DIND

Identifier Type: -

Identifier Source: org_study_id

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