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Swallowing Evaluation by HRIM in Patients With Cervical Spondylosis

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National Taiwan University

Status

Not yet enrolling

Conditions

Upper Esophageal Sphincter Relaxing Pressure

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT05713968
202211062DIND

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

patients with EAT-10 higher than 3 or frailty questionnaire higher than 2
Description:
patients may have high risk of aspiration
Treatment:
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
Description:
patients may have low risk of aspiration
Treatment:
Other: patients with EAT-10 lower than 3 or frailty questionnaire lower than 2

Trial contacts and locations

0

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Central trial contact

Chih-Jun Lai, MD

Data sourced from clinicaltrials.gov

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