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Status unknownNCT03306134BETASPUpdated Feb 22, 2018

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

An observational study in Beta Blockers, Swallowing Disorder and Substance P, sponsored by Hospital de Mataró. Status unknown at 1 site in Spain. Per ClinicalTrials.gov, last updated 2018-02-22.

Sponsored by Hospital de Mataró · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Sex
All
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Study 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.

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Conditions studied

  • Beta Blockers
  • Swallowing Disorder
  • Substance P

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All population.

Inclusion criteria

  • Patients taking and not taking beta-blockers

Exclusion criteria

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%.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • BETA-BLOCKERS

    Patients taking beta-blockers with or without dysphagia

    Diagnostic Test: Dysphagia

  • NO BETA-BLOCKERS

    Patients not taking beta-blockers with or without dysphagia

    Diagnostic Test: Dysphagia

Interventions

  • Diagnostic testDysphagia

    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)

    Also known as: Diagnostic test

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What researchers measure

Primary outcomes

  1. Substance P levels

    In blood and saliva

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • Mataró Hospital
    Mataró, Barcelona 08304, Spain
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03306134
Lead sponsor
Hospital de Mataró
Responsible party
Marta Miarons (Clinical pharmacist, Hospital de Mataró) — Principal investigator
First posted
Oct 10, 2017
Start date
Jun 5, 2017
Primary completion
Nov 25, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Feb 22, 2018

Study contacts

Marta Miarons
Contact
mmiarons@csdm.cat
0034600297227
Laia Rofes
Contact
Marta Miarons
principal investigator · Mataró Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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