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

Swallowing Disorder Clinical Trial

— BETASP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03306134
• Other study ID #: 2017/05
• Status: Recruiting
• Phase: N/A
• First received: September 22, 2017
• Last updated: February 21, 2018
• Start date: June 5, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2018
• Source: Hospital de Mataró
• Contact: Marta Miarons
• Phone: 0034600297227
• Email: mmiarons[@]csdm.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2018
• Est. primary completion date: November 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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%.

Related Conditions & MeSH terms

• Beta Blockers
• Deglutition Disorders
• Substance P
• Swallowing Disorder

Intervention

Diagnostic Test:
• Dysphagia
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)

Locations

Country	Name	City	State
Spain	Mataró Hospital	Mataró	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Mataró

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance P levels	In blood and saliva	1 year