Swallowing Evaluation in VF Immobility

• Conditions: Swallowing Disorder
• Interventions: Device: Videofluoroscopy

• Registration Number: NCT05473169
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2021-12-21
• Status Verified: 2022-07
• Study Start: 2022-07
• Study First Submitted QC: 2022-07-21
• Last Update Submitted: 2022-07-21
• Study First Posted: 2022-07-25
• Last Update Posted: 2022-07-25
• Primary Completion: 2023-07
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age:above 18.
2. Gender:both sexes will be included in the study.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Videofluoroscopy	Patients with Vocal fold immobility
Control	Videofluoroscopy	Normal volunteer don't have dysphagia , neurological diseases , heart burn and acid regurgitation

Primary Outcome Measures

Name	Time	Method
To calculate the incidence of swallowing dysfunction in people with vocal fold immobility	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 Outcome Measures

Name	Time	Method
Measure the frequency of each swallowing phase which will be affected in vocal fold immobility patients	Baseline	To detect which swallowing phase is causing the dysfunction by using Statistical Package for the Social Sciences (SPSS) program