Swallowing Evaluation in VF Immobility

Swallowing Disorder Clinical Trial

Official title:

Evaluation of Swallowing in Patients With Vocal Folds Immobility

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05473169
• Other study ID #: Swallowing in VF immobility
• Status: Not yet recruiting
• Start date: July 2022
• Est. completion date: August 2023

Study information

• Verified date: July 2022
• Source: Assiut University
• Contact: Mohamed Zakaria Ahmed Elbakry, Resident
• Phone: 01101941217
• Email: mohamedelbakry970[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Swallowing Disorder

Intervention

Device:
• Videofluoroscopy
Swallowing assessment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Heitmiller RF, Tseng E, Jones B. Prevalence of aspiration and laryngeal penetration in patients with unilateral vocal fold motion impairment. Dysphagia. 2000 Fall;15(4):184-7. — View Citation

Ollivere B, Duce K, Rowlands G, Harrison P, O'Reilly BJ. Swallowing dysfunction in patients with unilateral vocal fold paralysis: aetiology and outcomes. J Laryngol Otol. 2006 Jan;120(1):38-41. Epub 2005 Nov 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To calculate the incidence of swallowing dysfunction in people with vocal fold immobility	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)	Baseline
Secondary	Measure the frequency of each swallowing phase which will be affected in vocal fold immobility patients	To detect which swallowing phase is causing the dysfunction by using Statistical Package for the Social Sciences (SPSS) program	Baseline