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

NCT ID: NCT03306134

Last Updated: 2018-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-05

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Beta Blockers Swallowing Disorder Substance P

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BETA-BLOCKERS

Patients taking beta-blockers with or without dysphagia

Dysphagia

Intervention Type DIAGNOSTIC_TEST

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)

NO BETA-BLOCKERS

Patients not taking beta-blockers with or without dysphagia

Dysphagia

Intervention Type DIAGNOSTIC_TEST

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)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Diagnostic test

Eligibility Criteria

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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%.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital de Mataró

OTHER

Sponsor Role lead

Responsible Party

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Marta Miarons

Clinical pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marta Miarons

Role: PRINCIPAL_INVESTIGATOR

Mataró Hospital

Locations

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Mataró Hospital

Mataró, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Marta Miarons

Role: CONTACT

0034600297227

Laia Rofes

Role: CONTACT

Facility Contacts

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Marta Miarons

Role: primary

0034600297227

Laia Rofes

Role: backup

Other Identifiers

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2017/05

Identifier Type: -

Identifier Source: org_study_id

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