Swallowing DisorderNCT05473169
Swallowing Evaluation in VF Immobility
An observational study of Swallowing Disorder, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Swallowing Disorder
- What is being tested?
- Videofluoroscopy
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Vocal fold immobility
Who may be able to join
- Age:above 18.
- Gender:both sexes will be included in the study.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Swallowing in Patients With Vocal Folds Immobility
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
Read more
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
Read the 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.
- Conditions
- Swallowing Disorder
- Being tested
- Videofluoroscopy
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideofluoroscopyDevice
Also called Nasofibroscopy
Swallowing assessment
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with Vocal fold immobility Receives: Device: Videofluoroscopy | |
| Control | Normal volunteer don't have dysphagia , neurological diseases , heart burn and acid regurgitation Receives: Device: Videofluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Secondary outcomes (1)
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Swallowing DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Zakaria Ahmed Elbakry, Assiut University
- Investigators
- Assiut, Principal investigator, Non-afiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473169
- Sponsor's protocol ID
- Swallowing in VF immobility
- Status last verified
- Jul 2022
- First submitted
- 21 Dec 2021
- Last updated
- 25 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
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.
PubMed 11014880Ollivere 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.
PubMed 16359143
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Swallowing in Patients With Vocal Folds Immobility
- ClinicalTrials.gov ID
- NCT05473169
- Acronym / sponsor ID
- Swallowing in VF immobility
- Conditions
- Swallowing Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: VideofluoroscopyPatients with Vocal fold immobility |
| Control | – | Device: VideofluoroscopyNormal volunteer don't have dysphagia , neurological diseases , heart burn and acid regurgitation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Vocal fold immobility
Key inclusion criteria (2 listed)
- Age:above 18.
- Gender:both sexes will be included in the study.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideofluoroscopyAlso: NasofibroscopySwallowing assessment | Device | Control, Patients |
Primary outcome
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)
1 secondary outcome
Measure the frequency of each swallowing phase which will be affected in vocal fold immobility patients
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Background: PubMed 11014880Heitmiller 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.
- Background: PubMed 16359143Ollivere 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.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assiut principal investigator
Non-afiliated
Questions about this trial
What is this clinical trial studying?
An observational study of Swallowing Disorder, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Zakaria Ahmed Elbakry, Resident (01101941217, mohamedelbakry970@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To calculate the incidence of swallowing dysfunction in people with vocal fold immobility (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05473169, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022; AzTrials last refreshed its copy on 28 Oct 2026.