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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00015028 |
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Date of registration:
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15/11/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Bilateral vocal fold paralysis (BVFP): epidemiology and available treatments
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Scientific title:
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Bilateral vocal fold paralysis (BVFP): epidemiology and available treatments - 2015REG001 |
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Date of first enrolment:
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13/01/2016 |
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Target sample size:
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800 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00015028 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
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Phase:
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Countries of recruitment
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Austria
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Germany
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Spain
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Ukraine
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United Kingdom
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Contacts
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Name:
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Martin
Eisendle |
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Address:
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Fürstenweg 77a
6020
Innsbruck
Austria |
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Telephone:
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0043577885541 |
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Email:
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martin.eisendle@medel.com |
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Affiliation:
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MED-EL Elektromedizinische Geräte GmbH |
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Name:
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Orlando
Guntinas-Lichius |
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Address:
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Am Klinikum 1
07747
Jena
Germany |
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Telephone:
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004936419329301 |
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Email:
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Orlando.Guntinas@med.uni-jena.de |
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Affiliation:
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Universitätsklinikum Jena / Klinik für Hals-, Nasen- und Ohrenheilkunde |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Documented BVFP diagnosis
• Signed and dated informed consent before the start of any registry-specific procedures for subjects recruited prospectively
Exclusion criteria: • Lack of compliance with any inclusion criteria
• BVF Immobility (BVFI) not related to peripheral injuries of the RLN or to CNS diseases (e.g. ankyloses or stenosis)
• Parallel participation in a device/drug clinical investigation in the period of data collection, which could confound the results of the registry
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bilateral vocal fold paralysis
J38.03
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J38.03
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Intervention(s)
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Group 1: Since this is an observatory study, diagnosis, treatment and follow-ups follow the satndard procedures of the respective clinic. With voluntary permission of the patients, additional questionaires and/or diaries may be used. It is also possible that a physical activity monitor may be used that monitores the kind of physical activity patients engage in for several days, given that patients are interested and agree to the test. None of the additional testing is obligatory for patients.
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Primary Outcome(s)
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Due to the nature of this study, several aspects of the management of BVFP are evaluated equally. All data related to the diagnosis and management of BVFP is collected for either a 25 month periode after inclusion of a subject or earlier if the subject recovers from BVFP or has to be withdrawn for other reasons or drops out of the study.
The following information is collected at the beginning of the inclusion of a subject:
• BVFP Etiology and history
• Age
• Gender
• BVFP history
The following information /test results are collected for the entire duration of the registry, whenever they are available:
• Demographic information
• Medical history
• Medication history
• BVFP Progression
• BVFP treatment record (e.g. surgery report, patient’s discharge letter)
• Videolaryngoscopy
• Videolaryngostroboscopy
• Voice Range Profile, VRP
• Jitter
• Shimmer
• ‚Glottal to noise excitation rate‘ (GNE)
• Maximum Phonation Time, MPT
• s/z ratio
• Roughness, Breathiness, Hoarseness (RBH)
• Spirometry
• Body plethysmography
• Polysomnography (PSG)
• Standard text reading
• electrical Laryngeal Stimulation (eLS)
• Laryngeal Electromyography (LEMG)
• Fiberoptic endoscopic evaluation of swallowing (FEES)
• 6-Minuten Walk Test (6MWT)
• Questionnaires
• Voice Handicap Index (VHI)
• Short Form 36 (SF-36)
• Glasgow Benefit Index (GBI)
• St. George Respiratory Questionnaire (SGRQ)
• Pittsburgh Sleep Quality Index (PSQI)
• M. D. Anderson Dysphagia Inventory (MDADI)
• Clinic Choice and Travel (Non-validated questionnaire)
• Diary (e.g. PEF-meter use monitoring)
• PEF-Meter
• „Physical activity monitor“
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Secondary Outcome(s)
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not applicable
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Source(s) of Monetary Support
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MED-EL Elektromedizinische Geräte GmbH
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Ethics review
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Status: Approved
Approval date: 24/08/2015
Contact:
ethikkommission@med.uni-jena.de
Ethik-Kommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
+49-3641-9391191
ethikkommission@med.uni-jena.de
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