xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05963178</url>
    </required_header>
    <id_info>
      <org_study_id>5604</org_study_id>
      <nct_id>NCT05963178</nct_id>
    </id_info>
    <brief_title>Speech Therapy and Functional Dysphonia After Thyroidectomy</brief_title>
    <acronym>LSCC</acronym>
    <official_title>Effects of an Early Logopedic Management and Speech Therapy in Post-Thyroidectomy Central Compartment Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Following a thyroidectomy, voice and swallowing alterations, which more frequently would&#xD;
        appear to be caused by lesions of the laryngeal nerve, may occur. But, voice and swallowing&#xD;
        changes can also occur in the absence of lesions of the inferior laryngeal nerve or the&#xD;
        external branch of the superior laryngeal nerve, defining a condition called central&#xD;
        compartment syndrome or functional post-thyroidectomy syndrome. It has been demonstrated&#xD;
        that, in the presence of the aforementioned syndrome, the quality of the voice undergoes a&#xD;
        deterioration immediately after thyroidectomy surgery with a lowering of pitch.&#xD;
  &#xD;
        The purpose of this study will be to verify the effects of early speech therapy, including&#xD;
        pre-operative speech therapy counseling (during which the patient will be provided with&#xD;
        indications to be implemented in the immediate post-operative period).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Acoustic analysis (f0)</measure>
      <time_frame>3 months</time_frame>
      <description>Using the Multidimensional Voice Program, the Fundamental Frequency (F0, Hz) will be analyzed in the central 3 seconds of a sustained /a/.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acoustic analysis (NHR)</measure>
      <time_frame>3 months</time_frame>
      <description>Using the Multidimensional Voice Program, the noise/harmonics ratio (NHR) will be analyzed in the central 3 seconds of a sustained /a/.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acoustic analysis (Jitter%)</measure>
      <time_frame>3 months</time_frame>
      <description>Using the Multidimensional Voice Program, the Jitter (%) will be analyzed in the central 3 seconds of a sustained /a/.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acoustic analysis (Shimmer%)</measure>
      <time_frame>3 months</time_frame>
      <description>Using the Multidimensional Voice Program, the Shimmer (%) will be analyzed in the central 3 seconds of a sustained /a/.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Voice Range Profile (Flow)</measure>
      <time_frame>3 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Voice Range Profile (Fhigh)</measure>
      <time_frame>3 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Voice function</measure>
      <time_frame>3 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Swallowing function</measure>
      <time_frame>3 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Functional Dysphonia</condition>
    <arm_group>
      <arm_group_label>Cohort</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Pre-operative counselling</intervention_name>
      <description>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.&#xD;
  Patients will undergo phoniatric follow-up in the immediate post-operative period, at 7 days, 1 month and 3 months post-operatively.&#xD;
  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.</description>
      <arm_group_label>Cohort</arm_group_label>
      <other_name>Early speech therapy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  awaiting Total Thyroidectomy surgery&#xD;
  &#xD;
            -  able to sign a written consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Under the age of 21 or over the age of 65&#xD;
  &#xD;
            -  Previous vocal cord paralysis&#xD;
  &#xD;
            -  History of vocal or laryngeal pathologies that have required therapy&#xD;
  &#xD;
            -  Presence of speech disorders or lung pathologies&#xD;
  &#xD;
            -  Previous neck surgery&#xD;
  &#xD;
            -  Presence of malignant diseases&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ylenia Longobardi, SLP</last_name>
      <phone>0630155193</phone>
      <phone_ext>+39</phone_ext>
      <email>ylenia.longobardi@policlinicogemelli.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fondazione Policlinico Universitario A. Gemelli - IRCCS</name>
        <address>
          <city>Roma</city>
          <zip>00168</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ylenia Longobardi, SLP</last_name>
        <phone>0630155193</phone>
        <phone_ext>+39</phone_ext>
        <email>ylenia.longobardi@policlinicogemelli.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 5, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</investigator_affiliation>
      <investigator_full_name>LONGOBARDI YLENIA</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dysphonia</mesh_term>
      <mesh_term>Hoarseness</mesh_term>
      <mesh_term>Communication Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05963178
  org study id: 5604
  nct id: NCT05963178
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Acoustic analysis (f0)
  time frame: 3 months
  description: Using the Multidimensional Voice Program, the Fundamental Frequency (F0, Hz) will be analyzed in the central 3 seconds of a sustained /a/.
  measure: Acoustic analysis (NHR)
  time frame: 3 months
  description: Using the Multidimensional Voice Program, the noise/harmonics ratio (NHR) will be analyzed in the central 3 seconds of a sustained /a/.
  measure: Acoustic analysis (Jitter%)
  time frame: 3 months
  description: Using the Multidimensional Voice Program, the Jitter (%) will be analyzed in the central 3 seconds of a sustained /a/.
  measure: Acoustic analysis (Shimmer%)
  time frame: 3 months
  description: Using the Multidimensional Voice Program, the Shimmer (%) will be analyzed in the central 3 seconds of a sustained /a/.
  measure: Voice Range Profile (Flow)
  time frame: 3 months
  description: 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.
  measure: Voice Range Profile (Fhigh)
  time frame: 3 months
  description: 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.
  measure: Voice function
  time frame: 3 months
  description: 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).
  measure: Swallowing function
  time frame: 3 months
  description: 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).
  arm group label: Cohort
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: Pre-operative counselling
  description: 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.
  arm group label: Cohort
  other name: Early speech therapy
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Ylenia Longobardi, SLP
  phone: 0630155193
  phone ext: +39
  email: ylenia.longobardi@policlinicogemelli.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  investigator full name: LONGOBARDI YLENIA
  investigator title: Principal Investigator
  mesh term: Dysphonia
  mesh term: Hoarseness
  mesh term: Communication Disorders
  sharing ipd: No