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Clinical Trials/NCT05473169
NCT05473169
Unknown
Not Applicable

Evaluation of Swallowing in Patients With Vocal Folds Immobility

Assiut University0 sites40 target enrollmentJuly 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Swallowing Disorder
Sponsor
Assiut University
Enrollment
40
Primary Endpoint
To calculate the incidence of swallowing dysfunction in people with vocal fold immobility
Last Updated
3 years ago

Overview

Brief Summary

Vocal fold immobility (VFI) often results in significant problems with dysphonia, dysphagia, and decreased cough strength. As one element of the dysphagia potentially associated with vocal fold immobility,

aspiration may create significant morbidity for these patients. An estimated 38% to 53% of patients with

untreated VFI have swallowing difficulties with aspiration.

Vocal fold immobility has important implication on the laryngeal airway protection during respiration,

phonation and swallowing. It is the most common neurological laryngeal disorder.

The immobility may be caused by neck and thoracic surgery. which can impair the innervation of the pharynx,

upper esophageal sphincter (U.E.S) and proximal esophagus but may also be due to malignancy,trauma,

Intracranial causes,or may be idiopathic

Detailed Description

Besides the voice alteration, the lesion that causes of vocal fold immobility should also affect the pharyngeal phase of swallowing. It was suggested that dysphagia in patient with vocal fold immobility has multifactor causes ; including limited airway protection and decrease laryngopharyngeal sensation based on the finding of the flexible endoscopy. Another study revealed that pharyngeal phase abnormalities such as delayed initiation of swallowing, reduced laryngeal elevation, and reduced upper esophageal sphincter (UES) opening were found in video fluoroscopic swallowing studies (VFSS). Several studies on the swallowing difficulties of patient with vocal fold immobility has been performed and reported that nearly 56% of these patients immobility have swallowing dysfunction.

Registry
clinicaltrials.gov
Start Date
July 2022
End Date
August 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Zakaria Ahmed Elbakry

Principal investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Gender:both sexes will be included in the study.

Exclusion Criteria

  • patients with structural abnormalities of oral cavity, pharynx or larynx.
  • previous vocal fold injection or voice therapy.
  • other causes of dysphagia: esophageal cancer or spasm , gastric cancer, cancer larynx,or radio therapy .
  • . Patients with history of heart burn , acid regurgitation ,
  • other neurological disease ,stroke, hypothyroidism or dyspnea.

Outcomes

Primary Outcomes

To calculate the incidence of swallowing dysfunction in people with vocal fold immobility

Time Frame: Baseline

Incidence of swallowing dysfunction in patients with vocal fold immobility will be determined by the Statistical Package for the Social Sciences (SPPS) after the diagnosis of swallowing dysfunction by fiberoptic endoscopic evaluation of swallowing (FEES) and videofluoroscopic swallow study (VFSS)

Secondary Outcomes

  • Measure the frequency of each swallowing phase which will be affected in vocal fold immobility patients(Baseline)

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