The 'Lombard Effect' in Patients Affected by Adductor Laryngeal Dystonia
NCT06402214 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2024-05-07
Summary
Adductory spasmodic dysphonia (AdSD) is a rare condition characterised by irregular and uncontrolled voice interruptions, most commonly affecting women around the age of 45. The diagnosis is clinical and usually requires evaluation by several specialists. The exact cause is not known, but a disturbance of the motor system is hypothesised, probably related to various causes such as loss of cortical inhibition or problems with sensory input.
Neuroimaging studies have shown hyperactivity in various brain regions during speech production in patients with AdSD, but it is still unclear whether this hyperactivity is due to a malfunction of auditory and somatosensory feedback or an impairment of motor programming.
Recent research indicates that patients with AdSD show excessive muscle activation during phonation, probably due to abnormal processing of auditory feedback. This suggests that intervention in the auditory system may offer new treatment opportunities.
The proposed study aims to describe the acoustic, auditory-perceptual and subjective voice and speech changes in AdSD subjects during the Quick-Lombard Test (LT), a test that assesses vocal response under noisy conditions.
Conditions
- Adductor Spasmodic Dysphonia
Interventions
- OTHER
-
Lombard test
In this study a single-subject enrolment session will be set up, with the presence of a dedicated physician for informed consent, the performance of a tonal audiometric examination and a clinical practice phoniatric examination for all enrolled subjects, the collection of voice recordings both before and during the Lombard Test (LT) and the administration of the rating scales both before and after the LT performance. For each subject, voice recordings will be made of the vowel /a/ sustained for at least four seconds with a comfortable tone and volume and of the speech obtained from the reading aloud and volume of normal conversation of a phonetically balanced text (The Desert) lasting about 1 minute, first in a silent condition and then in the presence of noise. Specifically, for the LT, each subject will be exposed to a free-fieldwhite noise of speech(SWN) administered through headphones. The intensity of the noise will be 70 dB SPL. Voice recordings will be made in a quiet room.
Sponsors & Collaborators
-
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
lead OTHER
Principal Investigators
-
Maria Raffaella Marchese · Fondazione Policlinico Universitario A. Gemelli, IRCCS
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-05-01
- Primary Completion
- 2025-04-30
- Completion
- 2025-05-01
Countries
- Italy
Study Locations
More Related Trials
-
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
NCT02612337 ·Status: COMPLETED ·Phase: PHASE3
-
OTO-104 for the Treatment of Meniere's Disease
NCT01412177 ·Status: COMPLETED ·Phase: PHASE2
-
Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss
NCT02105441 ·Status: COMPLETED
-
Study of Lamotrigine to Treat Ménière's Disease
NCT02158585 ·Status: COMPLETED ·Phase: PHASE2
-
Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor
NCT07041203 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Comparing Topical Tetracaine Drops to Topical Focal Phenol for Local Anesthesia During Intratympanic Steroid Injection
NCT04794842 ·Status: ACTIVE_NOT_RECRUITING ·Phase: EARLY_PHASE1
-
Trial of the Treatment of Chronic Laryngitis With Amitryptiline
NCT02434523 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Anesthetizing the Tympanic Membrane in Healthy Volunteers
NCT01047904 ·Status: COMPLETED ·Phase: NA
-
Gastrodin Acupoint Injection for Sensorineural Hearing Loss With Vertigo
NCT07283562 ·Status: COMPLETED ·Phase: NA
-
Comparison of 3 Methods to Diagnose Endolymphatic Hydrops in Meniere's Disease
NCT03215420 ·Status: COMPLETED ·Phase: NA
-
A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients
NCT02102256 ·Status: COMPLETED ·Phase: PHASE1
-
Latanoprost for the Treatment of Menière's Disease
NCT01973114 ·Status: UNKNOWN ·Phase: PHASE2
-
OTO-104 for Meniere's Disease
NCT01084525 ·Status: COMPLETED ·Phase: PHASE1
-
A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound
NCT07304024 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Evaluation of the Diagnostic and Prognostic Efficacy of MRI in Acute Sensorineural Hearing Loss and Ménière's Disease
NCT06278129 ·Status: RECRUITING
-
Hearing Handicap in Patients With Single Sided Deafness
NCT02525640 ·Status: WITHDRAWN ·Phase: NA
-
A Study of a Mastoid Device in Subjects With Ménière's Disease
NCT03520322 ·Status: TERMINATED ·Phase: NA
-
A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom
NCT02265393 ·Status: COMPLETED ·Phase: PHASE2
-
The Effect of Patient's Position After Intra-tympanic Injection
NCT04384640 ·Status: UNKNOWN
-
Acceleration of the Kinetics of Diffusion of Gadolinium in the Perilymphatic Structures of the Inner Ear.
NCT04949321 ·Status: UNKNOWN ·Phase: NA
-
Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis
NCT00525551 ·Status: COMPLETED ·Phase: PHASE4
-
OTO-313 in Subjects With Unilateral Subjective Tinnitus
NCT04829214 ·Status: COMPLETED ·Phase: PHASE2
-
AM-101 in the Treatment of Acute Tinnitus 3
NCT02040194 ·Status: COMPLETED ·Phase: PHASE3
-
Blood Markers in Adult Patients With Sudden Sensorineural Hearing Loss (SSNHL)
NCT03919474 ·Status: COMPLETED
-
OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
NCT04129775 ·Status: COMPLETED ·Phase: PHASE1/PHASE2