Speech Therapy and Functional Dysphonia After Thyroidectomy (LSCC)

July 26, 2023 updated by: LONGOBARDI YLENIA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort
Behavioral: Pre-operative counselling

A preoperative speech therapy counseling will be carried out the day before the Total Thyroidectomy with the aim of informing patients about the possible conditions of the immediate post-operative period. Therefore, indications of vocal hygiene and hydration standards will be simultaneously administered, to be implemented from the first post-operative day.

Patients will undergo phoniatric follow-up in the immediate post-operative period, at 7 days, 1 month and 3 months post-operatively.

Patients who, at follow-up checks, should present the symptoms of functional post-thyroidectomy syndrome will undergo a cycle of post-operative speech therapy of 8 sessions.

Other Names:
  • Early speech therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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/.
3 months
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/.
3 months
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/.
3 months
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/.
3 months
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.
3 months
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.
3 months
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).
3 months
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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

November 30, 2023

Study Completion (Estimated)

January 31, 2024

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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