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XerostomiaXIvfNCT03009786

Validation of the French Version of the Xerostomia Inventory

An observational study of Xerostomia, run by CHU de Reims at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Xerostomia
What is being tested?
Measurement of salivary flow
How many people
65 participants
Where
1 siteFrance
Study dates
5 May 2017to 20 Feb 2024
Phase
Observational
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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: Elderly institutionalized subjects or outpatients aged 65 years or over

Who may be able to join

  • Age: 65 years or more
  • Outpatients or nursing home residents
  • Speaking French fluently
  • Willing to participate to the study

Who cannot join

  • Incapability to understand the instructions or to fill alone the questionnaire
  • Under guardianship

Trial locations and contacts

1 site in 1 country.

France1 site
  • Chu Reims

    Reims, 51092

Other trials in France

About this study

Official title: Cross-cultural and Psychometric Validation Version of the Xerostomia Inventory Into French Language

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.

Read the detailed description

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.

Conditions
Xerostomia
Being tested
Measurement of salivary flow
Medical subject headings
Xerostomia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Measurement of salivary flowOther

    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

Study groups in NCT03009786
Study groupRoleWhat they receive
Elderly institutionalized subjects or outpatientsNot described
Receives: Other: Measurement of salivary flow

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The psychometric properties of the Xerostomia Inventory measured by questionnaire

    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.

    Measured: month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2017 (estimated)
  2. Study start5 May 2017
  3. Primary completion27 Oct 2020
  4. Study completion20 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03009786
Sponsor's protocol ID
PO16109*
Acronym
XIvf
Status last verified
Feb 2024
First submitted
27 Dec 2016
Last updated
21 Feb 2024
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Xerostomia, run by CHU de Reims at 1 site in France.

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 4 inclusion and 2 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: finished, as of the sponsor's last update on 21 Feb 2024. 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 France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The psychometric properties of the Xerostomia Inventory measured by questionnaire (time frame: month 6). 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 21 Feb 2024.

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