Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-02-01 @ 2:19 PM
Study NCT ID:
NCT03306134
Status:
UNKNOWN
Last Update Posted:
2018-02-22
First Post:
2017-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Beta-blockers in Substance P Levels and the Swallowing Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003955', 'term': 'Diagnostic Tests, Routine'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-21', 'studyFirstSubmitDate': '2017-09-22', 'studyFirstSubmitQcDate': '2017-10-07', 'lastUpdatePostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Substance P levels', 'timeFrame': '1 year', 'description': 'In blood and saliva'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Beta Blockers', 'Swallowing Disorder', 'Substance P']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All population.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients taking and not taking beta-blockers\n\nExclusion Criteria:\n\n* Participants with heat and neck or esophageal cancer\n* Participants with stroke or neurological disease\n* Participants with central nervous system disease\n* Participants with concomitant treatment with Angiotensin converting enzyme inhibitors (ACEI), Angiotensin II receptor antagonists (ARA-II), Antipsychotics, Dopamine agonists, Capsaicine.\n* Participants with severe clinical signs of aspiration, including oxygen desaturation ≥3%.'}, 'identificationModule': {'nctId': 'NCT03306134', 'acronym': 'BETASP', 'briefTitle': 'The Effect of Beta-blockers in Substance P Levels and the Swallowing Function', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Mataró'}, 'officialTitle': 'The Effect of Beta-blockers in Substance P Levels and the Swallowing Function', 'orgStudyIdInfo': {'id': '2017/05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BETA-BLOCKERS', 'description': 'Patients taking beta-blockers with or without dysphagia', 'interventionNames': ['Diagnostic Test: Dysphagia']}, {'label': 'NO BETA-BLOCKERS', 'description': 'Patients not taking beta-blockers with or without dysphagia', 'interventionNames': ['Diagnostic Test: Dysphagia']}], 'interventions': [{'name': 'Dysphagia', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Diagnostic test'], 'description': 'An overall assessment is going to be carry out by a multidisciplinary team during the visit.\n\nSwallowing 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.\n\nAll subjects are going to be submitted to the volume-viscosity swallow test (V- VST)', 'armGroupLabels': ['BETA-BLOCKERS', 'NO BETA-BLOCKERS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08304', 'city': 'Mataró', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marta Miarons', 'role': 'CONTACT', 'email': 'mmiarons@csdm.cat', 'phone': '0034600297227'}, {'name': 'Laia Rofes', 'role': 'CONTACT'}], 'facility': 'Mataró Hospital', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}], 'centralContacts': [{'name': 'Marta Miarons', 'role': 'CONTACT', 'email': 'mmiarons@csdm.cat', 'phone': '0034600297227'}, {'name': 'Laia Rofes', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Marta Miarons', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mataró Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Mataró', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical pharmacist', 'investigatorFullName': 'Marta Miarons', 'investigatorAffiliation': 'Hospital de Mataró'}}}}