Functional DysphoniaLSCCNCT05963178
Speech Therapy and Functional Dysphonia After Thyroidectomy
A study testing Pre-operative counselling in people with Functional Dysphonia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Functional Dysphonia
- What is being tested?
- Pre-operative counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 31 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- awaiting Total Thyroidectomy surgery
- able to sign a written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli - IRCCS
Roma, 00168
Ylenia Longobardi, SLP, 0630155193 ext. +39, ylenia.longobardi@policlinicogemelli.it
About this study
Official title: Effects of an Early Logopedic Management and Speech Therapy in Post-Thyroidectomy Central Compartment Syndrome
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).
- Conditions
- Functional Dysphonia
- Being tested
- Pre-operative counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative counsellingBehavioural
Also called Early speech therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Experimental | Not described Receives: Behavioral: Pre-operative counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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/.
Measured: 3 months
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/.
Measured: 3 months
Acoustic analysis (Jitter%)
Using the Multidimensional Voice Program, the Jitter (%) will be analyzed in the central 3 seconds of a sustained /a/.
Measured: 3 months
Acoustic analysis (Shimmer%)
Using the Multidimensional Voice Program, the Shimmer (%) will be analyzed in the central 3 seconds of a sustained /a/.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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).
Measured: 3 months
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).
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 completion30 Nov 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DysphoniaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LONGOBARDI YLENIA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963178
- Sponsor's protocol ID
- 5604
- Acronym
- LSCC
- Status last verified
- Jul 2023
- First submitted
- 5 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Early Logopedic Management and Speech Therapy in Post-Thyroidectomy Central Compartment Syndrome
- ClinicalTrials.gov ID
- NCT05963178
- Acronym / sponsor ID
- LSCC / 5604
- Conditions
- Functional Dysphonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Experimental | Behavioral: Pre-operative counselling |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- awaiting Total Thyroidectomy surgery
- able to sign a written consent
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Pre-operative counsellingAlso: Early speech therapyA 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. | Behavioural | Cohort |
Primary outcome
Acoustic analysis (f0)
Time frame: 3 months
Using the Multidimensional Voice Program, the Fundamental Frequency (F0, Hz) will be analyzed in the central 3 seconds of a sustained /a/.
Acoustic analysis (NHR)
Time frame: 3 months
Using the Multidimensional Voice Program, the noise/harmonics ratio (NHR) will be analyzed in the central 3 seconds of a sustained /a/.
Acoustic analysis (Jitter%)
Time frame: 3 months
Using the Multidimensional Voice Program, the Jitter (%) will be analyzed in the central 3 seconds of a sustained /a/.
Acoustic analysis (Shimmer%)
Time frame: 3 months
Using the Multidimensional Voice Program, the Shimmer (%) will be analyzed in the central 3 seconds of a sustained /a/.
Voice Range Profile (Flow)
Time frame: 3 months
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.
Voice Range Profile (Fhigh)
Time frame: 3 months
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.
Voice function
Time frame: 3 months
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).
Swallowing function
Time frame: 3 months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-operative counselling in people with Functional Dysphonia, 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 6 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ylenia Longobardi, SLP (0630155193 ext. +39, ylenia.longobardi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acoustic analysis (f0) (time frame: 3 months). The study lists 8 primary outcomes in all. 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 27 Jul 2023.