The Unilateral Vocal Fold Paralysis (UVFP): Epidemiology and Patient Management

The Unilateral Vocal Fold Paralysis (UVFP): Epidemiology and Patient Management - 2018REG002

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017329

Enrollment

384

Registered

2019-05-17

Start date

2019-03-18

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

J38.02

Interventions

Group 1: Since this is an observatory study, diagnosis, treatment and follow-ups follow the standard 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 UVFP 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 - Full recovery of UVFP - Impairment of vocal fold movement not related to peripheral injuries of the RLN e.g. UVF Immobility (UVFI) caused by ankyloses or stenosis and UVFP caused by diseases of the central nervous system - 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 UVFP are evaluated equally. All data related to the diagnosis and management of UVFP is collected for either a 25 month periode after inclusion of a subject or earlier if the subject has no follow-up visits, recovers from UVFP or has to be withdrawn for other reasons or drops out of the study.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: - UVFP Etiology and history - Age - Gender - UVFP 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 - UVFP Progression - UVFP treatment record (e.g. surgery report, patient’s discharge letter) - Videolaryngoscopy / Videolaryngostroboscopy - Voice Range Profile, VRP - Jitter - Shimmer - Maximum Phonation Time, MPT - Roughness, Breathiness, Hoarseness (RBH) - Spirometry / Body plethysmography - Laryngeal Electromyography (LEMG) - Fiberoptic endoscopic evaluation of swallowing (FEES) Questionnaires - Voice Handicap Index (VHI) - Short Form 36 (SF-36) - Glasgow Benefit Index (GBI) - St. George Respiratory Questionnaire (SGRQ) - Pittsburgh Sleep Quality Index (PSQI) - Sydney Swallow Questionnaire (SSQ) - Clinic Choice and Travel (Non-validated questionnaire) - Voice Problems Questionnaire (Non-validated questionnaire)	—

Measure

Time frame

Due to the nature of this study, several aspects of the management of UVFP are evaluated equally. All data related to the diagnosis and management of UVFP is collected for either a 25 month periode after inclusion of a subject or earlier if the subject has no follow-up visits, recovers from UVFP 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: - UVFP Etiology and history - Age - Gender - UVFP 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 - UVFP Progression - UVFP treatment record (e.g. surgery report, patient’s discharge letter) - Videolaryngoscopy / Videolaryngostroboscopy - Voice Range Profile, VRP - Jitter - Shimmer - Maximum Phonation Time, MPT - Roughness, Breathiness, Hoarseness (RBH) - Spirometry / Body plethysmography - Laryngeal Electromyography (LEMG) - Fiberoptic endoscopic evaluation of swallowing (FEES) Questionnaires - Voice Handicap Index (VHI) - Short Form 36 (SF-36) - Glasgow Benefit Index (GBI) - St. George Respiratory Questionnaire (SGRQ) - Pittsburgh Sleep Quality Index (PSQI) - Sydney Swallow Questionnaire (SSQ) - Clinic Choice and Travel (Non-validated questionnaire) - Voice Problems Questionnaire (Non-validated questionnaire)

—

Countries

Austria, Germany, Ukraine

Contacts

Public ContactVerena Rieger

MED-EL Elektromedizinische Geräte GmbH

Verena.Rieger@medel.com+43 664 60705 1230

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026