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

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ClinicalTrials.gov Identifier: NCT05963165
Recruitment Status : Recruiting
First Posted : July 27, 2023
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
D'Alatri Lucia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 1, 2023
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Degree of glottic closure [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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%) [ Time Frame: 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%) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 3 months ]
    the Maximum Phonatory Time (MPT) will be evaluated on a sustained /a/ (minimum 3 seconds)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05963165


Contacts
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Contact: Lucia D'Alatri, MD 0630155193 ext +39 lucia.dalatri@policlinicogemelli.it

Locations
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Italy
Fondazione Policlinico Universitario A. Gemelli - IRCCS Recruiting
Roma, Italy, 00168
Contact: Lucia D'Alatri, MD    0630155193 ext +39    lucia.dalatri@policlinicogemelli.it   
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
More Information
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Responsible Party: D'Alatri Lucia, Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT05963165    
Other Study ID Numbers: 5559
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vocal Cord Paralysis
Paralysis
Neurologic Manifestations
Nervous System Diseases
Laryngeal Diseases
 Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases