Beta BlockersBETASPNCT03306134
The Effect of Beta-blockers in Substance P Levels and the Swallowing Function
An observational study of Beta Blockers and Swallowing Disorder, run by Hospital de Mataró at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Beta Blockers, Swallowing Disorder, Substance P
- What is being tested?
- Dysphagia
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jun 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All population.
Who may be able to join
- Patients taking and not taking beta-blockers
Who cannot join
- 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%.
Trial locations and contacts
1 site in 1 country.
Laia Rofes contact
Spain1 site, 1 recruiting
- Recruiting
Mataró Hospital
Mataró, Barcelona, 08304
Marta Miarons, 0034600297227, mmiarons@csdm.cat
Laia Rofes
About this study
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.
- Conditions
- Beta Blockers, Swallowing Disorder, Substance P
- Being tested
- Dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DysphagiaDiagnostic test
Also called 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)
| Study group | Role | What they receive |
|---|---|---|
| BETA-BLOCKERS | Patients taking beta-blockers with or without dysphagia Receives: Diagnostic Test: Dysphagia | |
| NO BETA-BLOCKERS | Patients not taking beta-blockers with or without dysphagia Receives: Diagnostic Test: Dysphagia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance P levels
In blood and saliva
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start5 Jun 2017
- Primary completion25 Nov 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta BlockersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Mataró
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Miarons, Hospital de Mataró
- Investigators
- Marta Miarons, Principal investigator, Mataró Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306134
- Sponsor's protocol ID
- 2017/05
- Acronym
- BETASP
- Status last verified
- Feb 2018
- First submitted
- 22 Sep 2017
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Beta-blockers in Substance P Levels and the Swallowing Function
- ClinicalTrials.gov ID
- NCT03306134
- Acronym / sponsor ID
- BETASP / 2017/05
- Conditions
- Beta Blockers, Swallowing Disorder, Substance P
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 25 Nov 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 10 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BETA-BLOCKERS | – | Diagnostic Test: DysphagiaPatients taking beta-blockers with or without dysphagia |
| NO BETA-BLOCKERS | – | Diagnostic Test: DysphagiaPatients not taking beta-blockers with or without dysphagia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All population.
Key inclusion criteria (1 listed)
- Patients taking and not taking beta-blockers
Key exclusion criteria (5 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DysphagiaAlso: Diagnostic testAn 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) | Diagnostic test | BETA-BLOCKERS, NO BETA-BLOCKERS |
Primary outcome
Substance P levels
Time frame: 1 year
In blood and saliva
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laia Rofes contact
Marta Miarons principal investigator
Mataró Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Beta Blockers and Swallowing Disorder, run by Hospital de Mataró at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Miarons (0034600297227, mmiarons@csdm.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance P levels (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.