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/NCT05963165</url>
    </required_header>
    <id_info>
      <org_study_id>5559</org_study_id>
      <nct_id>NCT05963165</nct_id>
    </id_info>
    <brief_title>Non-phonatory Exercises in Patients With Unilateral Vocal Fold Paralysis Post-thyroidectomy</brief_title>
    <acronym>ENFP</acronym>
    <official_title>Early Speech Therapy Using Non-phonatory Exercises in Patients With Unilateral Vocal Fols Paralysis After Thyroidectomy: a Randomized Clinical Trial</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>
        Thyroidectomy is the most common iatrogenic cause of vocal fold paralysis. Patients complain&#xD;
        of hoarseness caused by incomplete glottic closure and have effort to raise vocal intensity&#xD;
        with consequent elevation of the larynx and/or involvement of supraglottic structures in&#xD;
        phonation. These compensation mechanisms result in a shift of the fundamental frequency&#xD;
        towards more serious tones or falsetto voice emissions.&#xD;
  &#xD;
        The first choice treatment is speech therapy which aims to obtain better glottic closure,&#xD;
        preventing ankylosis of the crico-arytenoid joint. In order to promote better glottic closure&#xD;
        without risking the onset or increase of dysfunctional compensation, the idea behind this&#xD;
        project is to propose non-phonatory adduction exercises in the first post-operative week.&#xD;
  &#xD;
        The primary objective of the study is to compare patients who will perform non-phonatory&#xD;
        exercises in parallel with medical therapy for one week and patients who will perform&#xD;
        standard medical therapy only during the first week.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Degree of glottic closure</measure>
      <time_frame>3 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Acoustic analysis (fundamental frequency)</measure>
      <time_frame>3 months</time_frame>
      <description>Through the use of the &quot;Praat&quot; software, on the reading of the piece &quot;The desert&quot; and on a sustained /a/ the Fundamental Frequency (F0, Hz) will be analysed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acoustic analysis (NHR)</measure>
      <time_frame>3 months</time_frame>
      <description>Through the use of the &quot;Praat&quot; software, on the reading of the piece &quot;The desert&quot; and on a sustained /a/ the noise/harmonics ratio (NHR) will be analysed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acoustic analysis (Jitter%)</measure>
      <time_frame>3 months</time_frame>
      <description>Through the use of the &quot;Praat&quot; software, on the reading of the piece &quot;The desert&quot; and on a sustained /a/ the Jitter (%) will be analysed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acoustic analysis (Shimmer%)</measure>
      <time_frame>3 months</time_frame>
      <description>Through the use of the &quot;Praat&quot; software, on the reading of the piece &quot;The desert&quot; and on a sustained /a/ the Shimmer ( %) will be analysed.&#xD;
  f</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acoustic analysis (Flow)</measure>
      <time_frame>3 months</time_frame>
      <description>Through the use of the &quot;Praat&quot; software, on the reading of the piece &quot;The desert&quot; and on a sustained /a/ the minimum frequency (Flow) will be analysed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acoustic analysis (Fhigh)</measure>
      <time_frame>3 months</time_frame>
      <description>Through the use of the &quot;Praat&quot; software, on the reading of the piece &quot;The desert&quot; and on a sustained /a/ the maximum frequency (Fhigh) will be analysed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acoustic analysis (intensity)</measure>
      <time_frame>3 months</time_frame>
      <description>Through the use of the &quot;Praat&quot; software, on the reading of the piece &quot;The desert&quot; and on a sustained /a/ the intensity (dB) will be analysed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MPT</measure>
      <time_frame>3 months</time_frame>
      <description>the Maximum Phonatory Time (MPT) will be evaluated on a sustained /a/ (minimum 3 seconds)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Unilateral Vocal Cord Paralysis</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients who will perform non-phonatory exercises in parallel with medical therapy for the first week</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>patients who will perform standard medical therapy only during the first week.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Non-phonatory exercises</intervention_name>
      <description>Muscle exercises that favor glottic adduction without vocal emissions</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  vocal fold paralysis after thyrodectomy&#xD;
  &#xD;
            -  ability to sign an informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Vocal fold paralysis with different etiology&#xD;
  &#xD;
            -  Previous history of laryngeal, pulmonary or gastric surgery&#xD;
  &#xD;
            -  History of vocal or laryngeal pathologies that have required therapy&#xD;
  &#xD;
            -  Current or previous lung disorders&#xD;
  &#xD;
            -  Hearing loss&#xD;
  &#xD;
            -  Motor or neurological deficits&#xD;
  &#xD;
            -  Presence of malignant diseases&#xD;
  &#xD;
            -  Presence of speech or reading disorders&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Lucia D'Alatri, MD</last_name>
      <phone>0630155193</phone>
      <phone_ext>+39</phone_ext>
      <email>lucia.dalatri@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>Lucia D'Alatri, MD</last_name>
        <phone>0630155193</phone>
        <phone_ext>+39</phone_ext>
        <email>lucia.dalatri@policlinicogemelli.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 4, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 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>D'Alatri Lucia</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>Vocal Cord Paralysis</mesh_term>
      <mesh_term>Paralysis</mesh_term>
    </condition_browse>
    <!-- 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/NCT05963165
  org study id: 5559
  nct id: NCT05963165
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: Degree of glottic closure
  time frame: 3 months
  description: 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.
  measure: Acoustic analysis (fundamental frequency)
  time frame: 3 months
  description: 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.
  measure: Acoustic analysis (NHR)
  time frame: 3 months
  description: 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.
  measure: Acoustic analysis (Jitter%)
  time frame: 3 months
  description: 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.
  measure: Acoustic analysis (Shimmer%)
  time frame: 3 months
  description: 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
  measure: Acoustic analysis (Flow)
  time frame: 3 months
  description: 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.
  measure: Acoustic analysis (Fhigh)
  time frame: 3 months
  description: 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.
  measure: Acoustic analysis (intensity)
  time frame: 3 months
  description: 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.
  measure: MPT
  time frame: 3 months
  description: the Maximum Phonatory Time (MPT) will be evaluated on a sustained /a/ (minimum 3 seconds)
  arm group label: Experimental group
  arm group type: Experimental
  description: Patients who will perform non-phonatory exercises in parallel with medical therapy for the first week
  arm group label: Control group
  arm group type: No Intervention
  description: patients who will perform standard medical therapy only during the first week.
  intervention type: Behavioral
  intervention name: Non-phonatory exercises
  description: Muscle exercises that favor glottic adduction without vocal emissions
  arm group label: Experimental group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lucia D'Alatri, MD
  phone: 0630155193
  phone ext: +39
  email: lucia.dalatri@policlinicogemelli.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  investigator full name: D'Alatri Lucia
  investigator title: Principal Investigator
  mesh term: Vocal Cord Paralysis
  mesh term: Paralysis