Bilateral vocal fold paralysis (BVFP): epidemiology and available treatments

Bilateral vocal fold paralysis (BVFP): epidemiology and available treatments - 2015REG001

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00015028

Enrollment

800

Registered

2018-11-15

Start date

2016-01-13

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilateral vocal fold paralysis J38.03

Interventions

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 question

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Documented BVFP diagnosis • Signed and dated informed consent before the start of any registry-specific procedures for subjects recruited prospectively

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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for either a 25 month periode after inclusion of a subject or earlier if the subject recovers from BVFP or has to be withdrawn for other reasons or drops out of the study.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“	—

Measure

Time frame

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“

—

Countries

Austria, Germany, Spain, Ukraine, United Kingdom

Contacts

Public ContactMartin Eisendle

MED-EL Elektromedizinische Geräte GmbH

martin.eisendle@medel.com+43664607055541

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026