Speech Therapy and Functional Dysphonia After Thyroidectomy

Functional Dysphonia Clinical Trial

— LSCC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05963178
• Other study ID #: 5604
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: July 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Ylenia Longobardi, SLP
• Phone: 0630155193
• Email: ylenia.longobardi[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 31, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Communication Disorders
• Dysphonia
• Functional Dysphonia
• Hoarseness

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli - IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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/.	3 months
Primary	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/.	3 months
Primary	Acoustic analysis (Jitter%)	Using the Multidimensional Voice Program, the Jitter (%) will be analyzed in the central 3 seconds of a sustained /a/.	3 months
Primary	Acoustic analysis (Shimmer%)	Using the Multidimensional Voice Program, the Shimmer (%) will be analyzed in the central 3 seconds of a sustained /a/.	3 months
Primary	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.	3 months
Primary	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.	3 months
Primary	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).	3 months
Primary	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).	3 months