The Spasmodic Dysphonia (SD): Epidemiology and Patient Management

• Conditions: G24.8; Other dystonia

• Registration Number: DRKS00019933
• Lead Sponsor: MED-EL Elektromedizinische Geräte GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-21
• Study Completion: 2021-04-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

•Age = 18 years
•Patients diagnosed with adductory Spasmodic Dysphonia
•Signed and dated informed consent before the start of any registry-specific procedure for all the recruited subjects.

Exclusion Criteria

•Lack of compliance with any inclusion criteria
•Other clinical diseases that might result in alteration of the outcomes of this registry (e.g. muscular and/or skin diseases, epilepsy)
•Parallel participation in a device/drug clinical investigation in the period of data collec-tion, which could confound the results of the Registry 2018REG003.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The results of the following tests and questionnaires will be collected for a 13 month periode, provided they were used in regular clinical practice:<br>•Maximum Phonation Time, MPT<br>•F0 measured during reading 10 sentences rich in vowels with normal pitch<br>•Number of spasms during reading 10 sentences rich in vowels with normal pitch<br>•Strain assessment during reading 10 sentences rich in vowels with normal pitch<br>•Medical and medicinal history and current SD symptoms<br>•LEMG<br>•Videolaryngoscopy and Videolaryngostroboscopy<br>•Voice Range Profile, VRP<br>•Fundamental frequencies (F0)<br>•sound pressure level<br>•Jitter<br>•Dysphonia Severity Index (DSI)<br>•Roughness, Breathiness, and Hoarseness (RBH) <br>•Voice Handicap Index (VHI-9i)<br>•Overall phonation effort estimation<br>•Sydney Swallow Questionnaire <br>•Glasgow Benefit Inventory (GBI)<br>•Communicative Participation Item Bank (CPIB; Short Version)<br>•Voice Problems Questionnaire<br>•Diary.

Secondary Outcome Measures

Name	Time	Method
The following data will be collected for a 13 month periode, provided they were recorded in the course of the regular clinical practice:<br>•Medical record<br>•Demographic Data (age, gender, hight, weight)