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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03306134
Other study ID # 2017/05
Secondary ID
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
Health authority
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%.

Study Design


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
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