Unilateral Vocal Cord ParalysisENFPNCT05963165
Non-phonatory Exercises in Patients with Unilateral Vocal Fold Paralysis Post-thyroidectomy
A study testing Non-phonatory exercises in people with Unilateral Vocal Cord Paralysis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unilateral Vocal Cord Paralysis
- What is being tested?
- Non-phonatory exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- vocal fold paralysis after thyrodectomy
- ability to sign an informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli - IRCCS
Roma, Italy, 00168
About this study
Official title: Early Speech Therapy Using Non-phonatory Exercises in Patients with Unilateral Vocal Fols Paralysis After Thyroidectomy: a Randomized Clinical Trial
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.
- Conditions
- Unilateral Vocal Cord Paralysis
- Being tested
- Non-phonatory exercises
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-phonatory exercisesBehavioural
Muscle exercises that favor glottic adduction without vocal emissions
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients who will perform non-phonatory exercises in parallel with medical therapy for the first week Receives: Behavioral: Non-phonatory exercises |
| Control group | No intervention | patients who will perform standard medical therapy only during the first week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of glottic closure
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.
Measured: 3 months
Secondary outcomes (8)
Acoustic analysis (fundamental frequency)
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.
Measured: 3 months
Acoustic analysis (NHR)
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.
Measured: 3 months
Acoustic analysis (Jitter%)
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.
Measured: 3 months
Acoustic analysis (Shimmer%)
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
Measured: 3 months
Acoustic analysis (Flow)
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.
Measured: 3 months
Acoustic analysis (Fhigh)
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.
Measured: 3 months
Acoustic analysis (intensity)
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.
Measured: 3 months
MPT
the Maximum Phonatory Time (MPT) will be evaluated on a sustained /a/ (minimum 3 seconds)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Jul 2023
- Primary completion1 Oct 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Vocal Cord ParalysisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, D'Alatri Lucia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963165
- Sponsor's protocol ID
- 5559
- Acronym
- ENFP
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Speech Therapy Using Non-phonatory Exercises in Patients with Unilateral Vocal Fols Paralysis After Thyroidectomy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05963165
- Acronym / sponsor ID
- ENFP / 5559
- Conditions
- Unilateral Vocal Cord Paralysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Non-phonatory exercisesPatients who will perform non-phonatory exercises in parallel with medical therapy for the first week |
| Control group | No intervention | –patients who will perform standard medical therapy only during the first week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- vocal fold paralysis after thyrodectomy
- ability to sign an informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-phonatory exercisesMuscle exercises that favor glottic adduction without vocal emissions | Behavioural | Experimental group |
Primary outcome
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.
8 secondary outcomes
Acoustic analysis (fundamental frequency)
Time frame: 3 months
Acoustic analysis (NHR)
Time frame: 3 months
Acoustic analysis (Jitter%)
Time frame: 3 months
Acoustic analysis (Shimmer%)
Time frame: 3 months
Acoustic analysis (Flow)
Time frame: 3 months
Acoustic analysis (Fhigh)
Time frame: 3 months
Acoustic analysis (intensity)
Time frame: 3 months
MPT
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-phonatory exercises in people with Unilateral Vocal Cord Paralysis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of glottic closure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.