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Completed

NCT Number: NCT05963165

Non-phonatory Exercises in Patients with Unilateral Vocal Fold Paralysis Post-thyroidectomy

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.

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Key information

Conditions

Unilateral Vocal Cord Paralysis Cranial Nerve Diseases Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Paralysis Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Vagus Nerve Diseases Vocal Cord Paralysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli - IRCCS

Roma, Italy, 00168

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-phonatory exercises

Behavioral

Muscle exercises that favor glottic adduction without vocal emissions

Primary outcomes

  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 outcomes

  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.

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  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)

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Early Speech Therapy Using Non-phonatory Exercises in Patients with Unilateral Vocal Fols Paralysis After Thyroidectomy: a Randomized Clinical Trial

Acronym: ENFP

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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