The Effect of Beta-blockers in Substance P Levels and the Swallowing Function

Study Overview
=================
Brief Summary
-----------------
A non-randomised, prospective study to assess the effects of beta-blockers on substance P levels and the swallowing function. The study is going to be carry out in the Gastrointestinal Physiology Laboratory of the Hospital de Mataró (Spain). All participants will be actively recruited from a Linked hospital and primary care database. We include two groups: the first group (group 1) are participants taking beta-blockers and the second group (group 2) are participants not-taking beta-blockers.

Official Title
-----------------
The Effect of Beta-blockers in Substance P Levels and the Swallowing Function

Conditions
-----------------
Beta Blockers, Swallowing Disorder, Substance P

Intervention / Treatment
-----------------
* Diagnostic Test: Dysphagia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients taking and not taking beta-blockers Exclusion Criteria: Participants with heat and neck or esophageal cancer Participants with stroke or neurological disease Participants with central nervous system disease Participants with concomitant treatment with Angiotensin converting enzyme inhibitors (ACEI), Angiotensin II receptor antagonists (ARA-II), Antipsychotics, Dopamine agonists, Capsaicine. Participants with severe clinical signs of aspiration, including oxygen desaturation ≥3%.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BETA-BLOCKERS<br>Patients taking beta-blockers with or without dysphagia | Diagnostic Test: Dysphagia<br>* An overall assessment is going to be carry out by a multidisciplinary team during the visit. Swallowing assessment is going to be performed during the visit. We are going to use: (i) the Eating Assessment Tool (EAT-10), which is a short 10-item, easy to use, self-administered questionnaire [4]. Although the EAT-10 is considered to be predominantly a questionnaire on FHS, some items on HR-QoL are also included. The sum score of this 10-item questionnaire ranges from 0 to 40, and (ii) the Sydney Swallowing Questionnaire (SSQ) to clinically assess the severity of the symptoms of dysphagia, if present. All subjects are going to be submitted to the volume-viscosity swallow test (V- VST)<br>* Other names: Diagnostic test;|
| NO BETA-BLOCKERS<br>Patients not taking beta-blockers with or without dysphagia | Diagnostic Test: Dysphagia<br>* An overall assessment is going to be carry out by a multidisciplinary team during the visit. Swallowing assessment is going to be performed during the visit. We are going to use: (i) the Eating Assessment Tool (EAT-10), which is a short 10-item, easy to use, self-administered questionnaire [4]. Although the EAT-10 is considered to be predominantly a questionnaire on FHS, some items on HR-QoL are also included. The sum score of this 10-item questionnaire ranges from 0 to 40, and (ii) the Sydney Swallowing Questionnaire (SSQ) to clinically assess the severity of the symptoms of dysphagia, if present. All subjects are going to be submitted to the volume-viscosity swallow test (V- VST)<br>* Other names: Diagnostic test;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance P levels | In blood and saliva | 1 year |