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Clinical Trials/NCT05963178
NCT05963178
Recruiting
Not Applicable

Effects of an Early Logopedic Management and Speech Therapy in Post-Thyroidectomy Central Compartment Syndrome

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country30 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Functional Dysphonia
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
30
Locations
1
Primary Endpoint
Acoustic analysis (Shimmer%)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Following a thyroidectomy, voice and swallowing alterations, which more frequently would appear to be caused by lesions of the laryngeal nerve, may occur. But, voice and swallowing changes can also occur in the absence of lesions of the inferior laryngeal nerve or the external branch of the superior laryngeal nerve, defining a condition called central compartment syndrome or functional post-thyroidectomy syndrome. It has been demonstrated that, in the presence of the aforementioned syndrome, the quality of the voice undergoes a deterioration immediately after thyroidectomy surgery with a lowering of pitch.

The purpose of this study will be to verify the effects of early speech therapy, including pre-operative speech therapy counseling (during which the patient will be provided with indications to be implemented in the immediate post-operative period).

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
January 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

LONGOBARDI YLENIA

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility Criteria

Inclusion Criteria

  • awaiting Total Thyroidectomy surgery
  • able to sign a written consent

Exclusion Criteria

  • Under the age of 21 or over the age of 65
  • Previous vocal cord paralysis
  • History of vocal or laryngeal pathologies that have required therapy
  • Presence of speech disorders or lung pathologies
  • Previous neck surgery
  • Presence of malignant diseases

Outcomes

Primary Outcomes

Acoustic analysis (Shimmer%)

Time Frame: 3 months

Using the Multidimensional Voice Program, the Shimmer (%) will be analyzed in the central 3 seconds of a sustained /a/.

Acoustic analysis (NHR)

Time Frame: 3 months

Using the Multidimensional Voice Program, the noise/harmonics ratio (NHR) will be analyzed in the central 3 seconds of a sustained /a/.

Voice Range Profile (Fhigh)

Time Frame: 3 months

The patient will be instructed in the production of a sustained /a/ from the lowest to the highest note, from minimum to maximum intensity. In this case, the Maximum frequency (Fhigh) will be analysed.

Acoustic analysis (f0)

Time Frame: 3 months

Using the Multidimensional Voice Program, the Fundamental Frequency (F0, Hz) will be analyzed in the central 3 seconds of a sustained /a/.

Acoustic analysis (Jitter%)

Time Frame: 3 months

Using the Multidimensional Voice Program, the Jitter (%) will be analyzed in the central 3 seconds of a sustained /a/.

Voice Range Profile (Flow)

Time Frame: 3 months

The patient will be instructed in the production of a sustained /a/ from the lowest to the highest note, from minimum to maximum intensity. In this case, the Minimum frequency (Flow) will be analysed.

Voice function

Time Frame: 3 months

A questionnaire called Voice Impairment Score (VIS) will be used, created specifically to investigate the frequency of voice alterations. The VIS consists of 10 items and can vary from a minimum score of 0 (no vocal alteration) to a maximum of 40 (maximum voice disturbance).

Swallowing function

Time Frame: 3 months

A questionnaire called Swallowing Impariment Scores (SIS) will be used, created specifically to investigate the frequency of swallowing alterations. The SIS consists of 5 items and can vary from a minimum score of 0 (no vocal alteration) to a maximum of 20 (maximum swallowing disturbance).

Study Sites (1)

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