<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03306134</url>
  </required_header>
  <id_info>
    <org_study_id>2017/05</org_study_id>
    <nct_id>NCT03306134</nct_id>
  </id_info>
  <brief_title>The Effect of Beta-blockers in Substance P Levels and the Swallowing Function</brief_title>
  <acronym>BETASP</acronym>
  <official_title>The Effect of Beta-blockers in Substance P Levels and the Swallowing Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Mataró</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Mataró</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A non-randomised, prospective study to assess the effects of beta-blockers on substance P&#xD;
      levels and the swallowing function. The study is going to be carry out in the&#xD;
      Gastrointestinal Physiology Laboratory of the Hospital de Mataró (Spain). All participants&#xD;
      will be actively recruited from a Linked hospital and primary care database. We include two&#xD;
      groups: the first group (group 1) are participants taking beta-blockers and the second group&#xD;
      (group 2) are participants not-taking beta-blockers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 5, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">November 25, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Substance P levels</measure>
    <time_frame>1 year</time_frame>
    <description>In blood and saliva</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Beta Blockers</condition>
  <condition>Swallowing Disorder</condition>
  <condition>Substance P</condition>
  <arm_group>
    <arm_group_label>BETA-BLOCKERS</arm_group_label>
    <description>Patients taking beta-blockers with or without dysphagia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NO BETA-BLOCKERS</arm_group_label>
    <description>Patients not taking beta-blockers with or without dysphagia</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Dysphagia</intervention_name>
    <description>An overall assessment is going to be carry out by a multidisciplinary team during the visit.&#xD;
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.&#xD;
All subjects are going to be submitted to the volume-viscosity swallow test (V- VST)</description>
    <arm_group_label>BETA-BLOCKERS</arm_group_label>
    <arm_group_label>NO BETA-BLOCKERS</arm_group_label>
    <other_name>Diagnostic test</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients taking and not taking beta-blockers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with heat and neck or esophageal cancer&#xD;
&#xD;
          -  Participants with stroke or neurological disease&#xD;
&#xD;
          -  Participants with central nervous system disease&#xD;
&#xD;
          -  Participants with concomitant treatment with Angiotensin converting enzyme inhibitors&#xD;
             (ACEI), Angiotensin II receptor antagonists (ARA-II), Antipsychotics, Dopamine&#xD;
             agonists, Capsaicine.&#xD;
&#xD;
          -  Participants with severe clinical signs of aspiration, including oxygen desaturation&#xD;
             ≥3%.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marta Miarons</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mataró Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marta Miarons</last_name>
    <phone>0034600297227</phone>
    <email>mmiarons@csdm.cat</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laia Rofes</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mataró Hospital</name>
      <address>
        <city>Mataró</city>
        <state>Barcelona</state>
        <zip>08304</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marta Miarons</last_name>
      <phone>0034600297227</phone>
      <email>mmiarons@csdm.cat</email>
    </contact>
    <contact_backup>
      <last_name>Laia Rofes</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>October 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>February 21, 2018</last_update_submitted>
  <last_update_submitted_qc>February 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Mataró</investigator_affiliation>
    <investigator_full_name>Marta Miarons</investigator_full_name>
    <investigator_title>Clinical pharmacist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03306134
org study id: 2017/05
nct id: NCT03306134
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Substance P levels
time frame: 1 year
description: In blood and saliva
arm group label: BETA-BLOCKERS
description: Patients taking beta-blockers with or without dysphagia
arm group label: NO BETA-BLOCKERS
description: Patients not taking beta-blockers with or without dysphagia
intervention type: Diagnostic Test
intervention name: Dysphagia
description: 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)
arm group label: BETA-BLOCKERS
arm group label: NO BETA-BLOCKERS
other name: Diagnostic test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marta Miarons
role: Principal Investigator
affiliation: Mataró Hospital
last name: Marta Miarons
phone: 0034600297227
email: mmiarons@csdm.cat
last name: Laia Rofes
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital de Mataró
investigator full name: Marta Miarons
investigator title: Clinical pharmacist
mesh term: Deglutition Disorders
sharing ipd: Undecided