Prevalence of Tapia's Syndrome in Weaning Unit (NCT06033144) | Clinical Trial Compass
RecruitingNot Applicable
Prevalence of Tapia's Syndrome in Weaning Unit
France247 participantsStarted 2023-04-07
Plain-language summary
Tapia syndrome is a rare and poorly understood pathology. It is defined by a concomitant attack of the recurrent (branch of X) and hypoglossal (XII) nerves of peripheral or central origin. It is characterized by the paralysis of a vocal cord and the ipsilateral half of tongue. This damage is most often unilateral but it can also be bilateral. It results in dysphonia and swallowing disorders.
Tapia syndrome is a rare and poorly understood pathology. To date, less than 100 cases have been described in the literature. Previous works are mainly case reports and literature reviews. No prevalence study has been performed to date. Furthermore, disagreements persist regarding the semiology. Indeed, the involvement of the soft palate is not always described.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Hospitalized in weaning unit
* Duration of orotracheal intubation in the ICU greater than 48 hours;
* Glasgow score greater than or equal to 13 ;
* Patient at least 18 years of age at the time of inclusion;
* Affiliation with a social security system or beneficiary of such a system ;
* Oral, free, informed and express consent of the patient.
Exclusion Criteria:
* Known history of ENT or neurological pathologies (stroke, head trauma, neurodegenerative disease, brain tumor, ENT cancer);
* Known tumors in the vicinity of the X-nerve pathway;
* Ortner's syndrome (left recurrent nerve compression through the left atrium in mitral stenosis);
* Left lung cancer with subaortic lesion;
* History of cervical adenopathy compressing the X nerve;
* Presence of a cervical or cerebral abscess;
* 24-hour ventilated patient;
* Refusal of the patient or designated trusted person to participate in the study;
* Person subject to a safeguard of justice measure ;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of Tapia's syndrome
Timeframe: through study completion, an average of 2 years