Clinical trial NCT05473169: Swallowing Evaluation in VF Immobility
Official title: Evaluation of Swallowing in Patients With Vocal Folds Immobility
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Swallowing Disorder
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Vocal fold immobility

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To calculate the incidence of swallowing dysfunction in people with vocal fold immobility
timeFrame: Baseline
Secondary outcomes:
measure: Measure the frequency of each swallowing phase which will be affected in vocal fold immobility patients
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Non-afiliated
name: Assiut
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1007/s004550000026.
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. doi: 10.1017/S0022215105003567. Epub 2005 Nov 25.