<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/NCT03009786</url>
  </required_header>
  <id_info>
    <org_study_id>PO16109</org_study_id>
    <nct_id>NCT03009786</nct_id>
  </id_info>
  <brief_title>Validation of the French Version of the Xerostomia Inventory</brief_title>
  <acronym>XIvf</acronym>
  <official_title>Cross-cultural and Psychometric Validation Version of the Xerostomia Inventory Into French Language</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Reims</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CHU de Reims</source>
  <brief_summary>
    <textblock>
      The main objective of this study is to achieve cross-cultural and psychometric validation of&#xD;
      the Xerostomia Inventory initially developed in English language into French Language. This&#xD;
      will be achieved in two stages: First, cross-cultural validation, and a second, psychometric&#xD;
      validation The cross-cultural validation will be performed according to the methodology of&#xD;
      the Institute for Work and Health, according to the recommended six phases. In a second step,&#xD;
      the psychometric validation will be done using longitudinal study. Indeed, an observational,&#xD;
      longitudinal, and prospective study will be set up. Analysis of the results will help define&#xD;
      the feasibility and acceptability of the tool, its validity (content validity, perceived&#xD;
      validity, construct validity, concurrent validity, and discriminant validity), its&#xD;
      reliability (internal consistency and reproducibility over time). Longitudinal follow-up of&#xD;
      patients is expected to also assess the predictive validity and responsiveness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Medical context:&#xD;
&#xD;
      There is an intra-individual and inter-individual variability in the production of saliva.&#xD;
      Various factors influence the production of saliva. Saliva flow tends to decrease with age,&#xD;
      sleep, emotional state, and to increase after eating, and during pregnancy. Some drugs&#xD;
      increase the salivary flow, others decrease it. Tobacco and alcohol tend to impair the&#xD;
      quality of the saliva. Furthermore, 43% of 40-64 years and 61% over 65 take at least one&#xD;
      antisialic medication. Lack of saliva can cause problems chewing, swallowing, speaking, and&#xD;
      tasting perceptions. There is an increase in the number of oropharyngeal candidiasis that&#xD;
      affects feeding behaviors and would be responsible for malnutrition in the elderly, and an&#xD;
      increase in the number of caries for subjects still toothed. For edentulous or partially&#xD;
      dentate subjects, salivary film plays two roles: the first is to allow adhesion of complete&#xD;
      or almost complete dentures; the following is to protect the oral mucosa. In subjects&#xD;
      suffering from mouth dryness the denture becomes difficult. In addition, saliva is essential&#xD;
      for the first phase of digestion, for the creation of a correct bolus. There are several&#xD;
      methods to measure the salivary flow. The most common include:&#xD;
&#xD;
        -  The measurement of salivary flow at rest, the subject leaves the saliva in his mouth&#xD;
           then allowed to flow slowly and spit into a funnel connected to a graduated tube for&#xD;
           either 6 or 12 minutes. This test can be performed either at rest or stimulated using a&#xD;
           paraffin cube or citric acid. These tests are long and therefore not suitable for the&#xD;
           elderly.&#xD;
&#xD;
        -  The salivary flow measurements using a compress weight of about 0.95 g is weighed and&#xD;
           then placed under the tongue of the subject for 5 minutes. Once the elapsed time, the&#xD;
           pad is weighed, a simple subtraction determines the weight of saliva produced in 5&#xD;
           minutes. This test can be done like the previous one at rest or after stimulation.&#xD;
&#xD;
      Secretion at rest varies authors 0,05mℓ / min 0,4mℓ / min. The mouth dryness is defined by a&#xD;
      total salivary flow rate below 0.1 unstimulated +/- 0,1mℓ / min ≤ 0.16 mℓ / min. The salivary&#xD;
      potential of hydrogen (pH) varies between 6.5 and 8.5. Decreased salivary flow will cause a&#xD;
      decrease in pH and promote the degradation of the oral health status.&#xD;
&#xD;
      Tool: The Xerostomia Inventory is a scale of measurement of xerostomia with eleven items used&#xD;
      in daily practice or research, which results in a sum score giving a score representing the&#xD;
      severity of the drought oral perceived by the subject. This tool was developed in 1999 and&#xD;
      covers both experimental and behavioral aspects of xerostomia, and showed acceptable&#xD;
      psychometric characteristics. Today, this tool is available in English, Spanish and&#xD;
      Portuguese languages With this study a tool to measure xerostomia will be available in&#xD;
      French; it may be used in clinical studies and in the daily practice of the dentist and or&#xD;
      speech therapists to obtain a subjective measure of dry mouth, particularly in the elderly&#xD;
      who are the most vulnerable subjects consequences of xerostomia. Currently there is no way to&#xD;
      measure xerostomia, it is difficult to assess the processes associated with the patient and&#xD;
      case treatment administered it is impossible to say whether it is effective or not.&#xD;
&#xD;
      The aim of this study is to achieve cross-cultural and psychometric validation version of the&#xD;
      Xerostomia Inventory into French Language.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 5, 2017</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">November 5, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The psychometric properties of the Xerostomia Inventory measured by questionnaire</measure>
    <time_frame>month 6</time_frame>
    <description>The Xerostomia Inventory to be validated is an 11-item summated rating scale which combines the responses to 11 individual items into a single continuous scale score which represents the severity of chronic xerostomia; higher scores represent more severe symptoms. Respondents are asked to choose one of five responses: Never: 1 point; Hardly ever: 2 points; Occasionally: 3 points; Fairly often: 4 points; Very often: 5 points; to the following statements referring to the previous 4 weeks.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Xerostomia</condition>
  <arm_group>
    <arm_group_label>Elderly institutionalized subjects or outpatients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Measurement of salivary flow</intervention_name>
    <description>A compress of about 0.95 g which is weighed and then placed under the tongue of the subject for 5 minutes. Once the time has elapsed, the compress is weighed, a simple subtraction determines the weight of saliva produced in 5 minutes</description>
    <arm_group_label>Elderly institutionalized subjects or outpatients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Elderly institutionalized subjects or outpatients aged 65 years or over&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 65 years or more&#xD;
&#xD;
          -  Outpatients or nursing home residents&#xD;
&#xD;
          -  Speaking French fluently&#xD;
&#xD;
          -  Willing to participate to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incapability to understand the instructions or to fill alone the questionnaire&#xD;
&#xD;
          -  Under guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Pierrard Loïc</last_name>
    <phone>326787878</phone>
    <phone_ext>0033</phone_ext>
    <email>docteur.pierrard@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Reims</name>
      <address>
        <city>France</city>
        <state>Reims</state>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Damien JOLLY</last_name>
      <phone>326788472</phone>
      <phone_ext>33</phone_ext>
      <email>djolly@chu-reims.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>August 5, 2021</last_update_submitted>
  <last_update_submitted_qc>August 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Xerostomia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03009786
org study id: PO16109
nct id: NCT03009786
lead sponsor: 
The main objective of this study is to achieve cross-cultural and psychometric validation of
      the Xerostomia Inventory initially developed in English language into French Language. This
      will be achieved in two stages: First, cross-cultural validation, and a second, psychometric
      validation The cross-cultural validation will be performed according to the methodology of
      the Institute for Work and Health, according to the recommended six phases. In a second step,
      the psychometric validation will be done using longitudinal study. Indeed, an observational,
      longitudinal, and prospective study will be set up. Analysis of the results will help define
      the feasibility and acceptability of the tool, its validity (content validity, perceived
      validity, construct validity, concurrent validity, and discriminant validity), its
      reliability (internal consistency and reproducibility over time). Longitudinal follow-up of
      patients is expected to also assess the predictive validity and responsiveness.
Medical context:

      There is an intra-individual and inter-individual variability in the production of saliva.
      Various factors influence the production of saliva. Saliva flow tends to decrease with age,
      sleep, emotional state, and to increase after eating, and during pregnancy. Some drugs
      increase the salivary flow, others decrease it. Tobacco and alcohol tend to impair the
      quality of the saliva. Furthermore, 43% of 40-64 years and 61% over 65 take at least one
      antisialic medication. Lack of saliva can cause problems chewing, swallowing, speaking, and
      tasting perceptions. There is an increase in the number of oropharyngeal candidiasis that
      affects feeding behaviors and would be responsible for malnutrition in the elderly, and an
      increase in the number of caries for subjects still toothed. For edentulous or partially
      dentate subjects, salivary film plays two roles: the first is to allow adhesion of complete
      or almost complete dentures; the following is to protect the oral mucosa. In subjects
      suffering from mouth dryness the denture becomes difficult. In addition, saliva is essential
      for the first phase of digestion, for the creation of a correct bolus. There are several
      methods to measure the salivary flow. The most common include:

        -  The measurement of salivary flow at rest, the subject leaves the saliva in his mouth
           then allowed to flow slowly and spit into a funnel connected to a graduated tube for
           either 6 or 12 minutes. This test can be performed either at rest or stimulated using a
           paraffin cube or citric acid. These tests are long and therefore not suitable for the
           elderly.

        -  The salivary flow measurements using a compress weight of about 0.95 g is weighed and
           then placed under the tongue of the subject for 5 minutes. Once the elapsed time, the
           pad is weighed, a simple subtraction determines the weight of saliva produced in 5
           minutes. This test can be done like the previous one at rest or after stimulation.

      Secretion at rest varies authors 0,05mℓ / min 0,4mℓ / min. The mouth dryness is defined by a
      total salivary flow rate below 0.1 unstimulated +/- 0,1mℓ / min ≤ 0.16 mℓ / min. The salivary
      potential of hydrogen (pH) varies between 6.5 and 8.5. Decreased salivary flow will cause a
      decrease in pH and promote the degradation of the oral health status.

      Tool: The Xerostomia Inventory is a scale of measurement of xerostomia with eleven items used
      in daily practice or research, which results in a sum score giving a score representing the
      severity of the drought oral perceived by the subject. This tool was developed in 1999 and
      covers both experimental and behavioral aspects of xerostomia, and showed acceptable
      psychometric characteristics. Today, this tool is available in English, Spanish and
      Portuguese languages With this study a tool to measure xerostomia will be available in
      French; it may be used in clinical studies and in the daily practice of the dentist and or
      speech therapists to obtain a subjective measure of dry mouth, particularly in the elderly
      who are the most vulnerable subjects consequences of xerostomia. Currently there is no way to
      measure xerostomia, it is difficult to assess the processes associated with the patient and
      case treatment administered it is impossible to say whether it is effective or not.

      The aim of this study is to achieve cross-cultural and psychometric validation version of the
      Xerostomia Inventory into French Language.
observational model: Cohort
time perspective: Prospective
measure: The psychometric properties of the Xerostomia Inventory measured by questionnaire
time frame: month 6
description: The Xerostomia Inventory to be validated is an 11-item summated rating scale which combines the responses to 11 individual items into a single continuous scale score which represents the severity of chronic xerostomia; higher scores represent more severe symptoms. Respondents are asked to choose one of five responses: Never: 1 point; Hardly ever: 2 points; Occasionally: 3 points; Fairly often: 4 points; Very often: 5 points; to the following statements referring to the previous 4 weeks.
arm group label: Elderly institutionalized subjects or outpatients
intervention type: Other
intervention name: Measurement of salivary flow
description: A compress of about 0.95 g which is weighed and then placed under the tongue of the subject for 5 minutes. Once the time has elapsed, the compress is weighed, a simple subtraction determines the weight of saliva produced in 5 minutes
arm group label: Elderly institutionalized subjects or outpatients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Pierrard Loïc
phone: 326787878
phone ext: 0033
email: docteur.pierrard@gmail.com
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Xerostomia