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Validation of the French Version of the Xerostomia Inventory

NCT03009786 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2024-02-21

No results posted yet for this study

Summary

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.

Conditions

  • Xerostomia

Interventions

OTHER

Measurement of salivary flow

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

Sponsors & Collaborators

  • CHU de Reims

    lead OTHER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-05
Primary Completion
2020-10-27
Completion
2024-02-20

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03009786 on ClinicalTrials.gov