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Speech Therapy and Functional Dysphonia After Thyroidectomy (LSCC)

Primary Purpose

Functional Dysphonia

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Pre-operative counselling
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dysphonia

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione Policlinico Universitario A. Gemelli - IRCCSRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort

Arm Description

Outcomes

Primary Outcome Measures

Acoustic analysis (f0)
Using the Multidimensional Voice Program, the Fundamental Frequency (F0, Hz) will be analyzed in the central 3 seconds of a sustained /a/.
Acoustic analysis (NHR)
Using the Multidimensional Voice Program, the noise/harmonics ratio (NHR) will be analyzed in the central 3 seconds of a sustained /a/.
Acoustic analysis (Jitter%)
Using the Multidimensional Voice Program, the Jitter (%) will be analyzed in the central 3 seconds of a sustained /a/.
Acoustic analysis (Shimmer%)
Using the Multidimensional Voice Program, the Shimmer (%) will be analyzed in the central 3 seconds of a sustained /a/.
Voice Range Profile (Flow)
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 Range Profile (Fhigh)
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.
Voice function
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
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).

Secondary Outcome Measures

Full Information

First Posted
July 5, 2023
Last Updated
July 26, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05963178
Brief Title
Speech Therapy and Functional Dysphonia After Thyroidectomy
Acronym
LSCC
Official Title
Effects of an Early Logopedic Management and Speech Therapy in Post-Thyroidectomy Central Compartment Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dysphonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Pre-operative counselling
Other Intervention Name(s)
Early speech therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acoustic analysis (f0)
Description
Using the Multidimensional Voice Program, the Fundamental Frequency (F0, Hz) will be analyzed in the central 3 seconds of a sustained /a/.
Time Frame
3 months
Title
Acoustic analysis (NHR)
Description
Using the Multidimensional Voice Program, the noise/harmonics ratio (NHR) will be analyzed in the central 3 seconds of a sustained /a/.
Time Frame
3 months
Title
Acoustic analysis (Jitter%)
Description
Using the Multidimensional Voice Program, the Jitter (%) will be analyzed in the central 3 seconds of a sustained /a/.
Time Frame
3 months
Title
Acoustic analysis (Shimmer%)
Description
Using the Multidimensional Voice Program, the Shimmer (%) will be analyzed in the central 3 seconds of a sustained /a/.
Time Frame
3 months
Title
Voice Range Profile (Flow)
Description
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.
Time Frame
3 months
Title
Voice Range Profile (Fhigh)
Description
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.
Time Frame
3 months
Title
Voice function
Description
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).
Time Frame
3 months
Title
Swallowing function
Description
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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ylenia Longobardi, SLP
Phone
0630155193
Ext
+39
Email
ylenia.longobardi@policlinicogemelli.it
Facility Information:
Facility Name
Fondazione Policlinico Universitario A. Gemelli - IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ylenia Longobardi, SLP
Phone
0630155193
Ext
+39
Email
ylenia.longobardi@policlinicogemelli.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Speech Therapy and Functional Dysphonia After Thyroidectomy

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