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Search / Trial NCT06402214

The 'Lombard Effect' in Patients Affected by Adductor Laryngeal Dystonia

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · May 2, 2024

Trial Information

Current as of August 22, 2025

Not yet recruiting

Keywords

Laryngeal Dystonia Spasmodic Dysphonia Lombard Effect Auditory System

ClinConnect Summary

This clinical trial is studying a condition called adductor spasmodic dysphonia (AdSD), which causes people to have interruptions in their voice, making it hard to speak clearly. This condition mainly affects women in their mid-40s and can be linked to problems in how the brain controls speech. Researchers want to understand how patients’ voices change when they try to speak in noisy environments, using a test called the Quick-Lombard Test. They believe that looking at how patients respond to sound could lead to better treatments in the future.

To participate in this study, you need to be a native Italian speaker aged between 18 and 65 with normal hearing. Unfortunately, people currently receiving treatment for dystonia, those who have had throat surgery, or anyone undergoing speech therapy or specific medications won't be eligible. If you join the trial, you can expect to take part in assessments that measure how your voice performs under different conditions. This research could help improve understanding and treatment options for individuals with AdSD.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Native Italian-speaking patients;
  • Normal hearing, hearing threshold \< 20 dB HL for frequencies from 0.5 to 4 KHz;
  • Age \>18 years and \<65 years;
  • Written informed consent.
  • Exclusion Criteria:
  • Non-Italian-speaking patients.
  • Patients undergoing treatment for dystonia.
  • Previous laryngeal surgery.
  • Patient undergoing speech therapy.
  • Patient undergoing dopaminergic therapy.
  • Inability to sustain phonation of sufficient duration \>3 seconds or to perform sufficient tests to assess vocal outcomes.
  • Lack of written informed consent.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Roma, , Italy

Patients applied

0 patients applied

Trial Officials

Maria Raffaella Marchese

Principal Investigator

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported