Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases

Sponsor
Kliniken Beelitz GmbH
Study ID
NCT04706234
Status
Recruiting

Conditions

  • Motor Neuron Disease
  • Multiple System Atrophy
  • Neurodegenerative Diseases
  • Parkinson Disease
  • Progressive Supranuclear Palsy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

This is a non-interventional observational study designed to systematically record the results of routine laryngeal examinations and specific characteristics of dysphagia in patients with neurodegenerative disorders. The results of a fiberoptic / flexible endoscopic evaluation of swallowing (FEES) while performing a structured task protocol will be recorded. If available, laryngeal electromyography (EMG) results will also be recorded. In addition to the examination results, demographic and disease-specific data are collected, and two questionnaires, the Swallowing Disturbance Questionnaire for Parkinson's Disease (SDQ-PD) and the swallowing specific Quality Of Life Questionnaire (SWALQOL), are administered.

Key Dates

First listed
Jan 12, 2021
Start date
Sep 1, 2017
Status verified
Apr 2025
Primary completion
Dec 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
350 participants (estimated)

Arms

  • Arm: Multiple System Atrophy
    Patients diagnosed will probable or possible MSA according to the 2nd criteria for the diagnosis of MSA (Gilman 2008) that received laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019).
  • Arm: progressive supranuclear palsy
    Patients diagnosed will probable or possible Progressive Supranuclear Palsy or (PSP) related 4repeat tauopathies according to the Movement Disorders Society diagnostic criteria (Höglinger 2017) that received laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019).
  • Arm: Parkinson Disease
    Patients diagnosed will Parkinson's disease according to the Movement Disorders Society diagnostic criteria (Postuma 2015) that received laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019).
  • Arm: Motor Neuron Disease
    Patients diagnosed with Motor Neuron Disease that received laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019).
  • Arm: Neurodegenerative Diseases
    Patients diagnosed with a neurodegenerative disease not specified above that received laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019).

Primary Outcome Measure

laryngeal movement disorders [ Time Frame: 1 day ]

Central Contacts

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