ENFP: Non-phonatory Exercises in Patients With Unilateral Vocal Fold Paralysis Post-thyroidectomy

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05963165
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 9.3

Study Details

Study Description

Brief Summary

Thyroidectomy is the most common iatrogenic cause of vocal fold paralysis. Patients complain of hoarseness caused by incomplete glottic closure and have effort to raise vocal intensity with consequent elevation of the larynx and/or involvement of supraglottic structures in phonation. These compensation mechanisms result in a shift of the fundamental frequency towards more serious tones or falsetto voice emissions.

The first choice treatment is speech therapy which aims to obtain better glottic closure, preventing ankylosis of the crico-arytenoid joint. In order to promote better glottic closure without risking the onset or increase of dysfunctional compensation, the idea behind this project is to propose non-phonatory adduction exercises in the first post-operative week.

The primary objective of the study is to compare patients who will perform non-phonatory exercises in parallel with medical therapy for one week and patients who will perform standard medical therapy only during the first week.

Condition or Disease	Intervention/Treatment	Phase
Unilateral Vocal Cord Paralysis	Behavioral: Non-phonatory exercises	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Early Speech Therapy Using Non-phonatory Exercises in Patients With Unilateral Vocal Fols Paralysis After Thyroidectomy: a Randomized Clinical Trial
• Actual Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group Patients who will perform non-phonatory exercises in parallel with medical therapy for the first week	Behavioral: Non-phonatory exercises; Muscle exercises that favor glottic adduction without vocal emissions
No Intervention: Control group patients who will perform standard medical therapy only during the first week.

Outcome Measures

Primary Outcome Measures

1. Degree of glottic closure [3 months]

   A videostrobolaryngoscopy will be performed. The recorded videos will be viewed by expert clinicians and a numerical score will be assigned relating to the degree of glottic adduction on a 7-point scale.

Secondary Outcome Measures

1. Acoustic analysis (fundamental frequency) [3 months]

   Through the use of the "Praat" software, on the reading of the piece "The desert" and on a sustained /a/ the Fundamental Frequency (F0, Hz) will be analysed.

2. Acoustic analysis (NHR) [3 months]

   Through the use of the "Praat" software, on the reading of the piece "The desert" and on a sustained /a/ the noise/harmonics ratio (NHR) will be analysed.

3. Acoustic analysis (Jitter%) [3 months]

   Through the use of the "Praat" software, on the reading of the piece "The desert" and on a sustained /a/ the Jitter (%) will be analysed.

4. Acoustic analysis (Shimmer%) [3 months]

   Through the use of the "Praat" software, on the reading of the piece "The desert" and on a sustained /a/ the Shimmer ( %) will be analysed. f

5. Acoustic analysis (Flow) [3 months]

   Through the use of the "Praat" software, on the reading of the piece "The desert" and on a sustained /a/ the minimum frequency (Flow) will be analysed.

6. Acoustic analysis (Fhigh) [3 months]

   Through the use of the "Praat" software, on the reading of the piece "The desert" and on a sustained /a/ the maximum frequency (Fhigh) will be analysed.

7. Acoustic analysis (intensity) [3 months]

   Through the use of the "Praat" software, on the reading of the piece "The desert" and on a sustained /a/ the intensity (dB) will be analysed.

8. MPT [3 months]

   the Maximum Phonatory Time (MPT) will be evaluated on a sustained /a/ (minimum 3 seconds)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• vocal fold paralysis after thyrodectomy

• ability to sign an informed consent

Exclusion Criteria:

• Vocal fold paralysis with different etiology

• Previous history of laryngeal, pulmonary or gastric surgery

• History of vocal or laryngeal pathologies that have required therapy

• Current or previous lung disorders

• Hearing loss

• Motor or neurological deficits

• Presence of malignant diseases

• Presence of speech or reading disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario A. Gemelli - IRCCS	Roma		Italy	00168

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: D'Alatri Lucia, Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05963165
• Other Study ID Numbers: 5559
• First Posted: Jul 27, 2023
• Last Update Posted: Jul 27, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vocal Cord Paralysis; Paralysis

Study Results

No Results Posted as of Jul 27, 2023