Olfactory and Taste Disturbances in Sjogren's Syndrome

NCT ID: NCT04909112

Last Updated: 2022-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-10-01

Brief Summary

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Sjögren syndrome is an autoimmune disease, responsible for xerostomia and xerophthalmia. Other organs and tissues can be affected: the skin, vaginal and nasal mucous membranes. As well, olfactory disorders have been also described in Sjögren syndrome.

Xerostomia often causes significant functional impairment of taste function. Impairment of taste function has been poorly evaluated in Sjögren syndrome like olfactory or (intra-nasal and oral) trigeminal disorders.

Detailed Description

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The aim of the study is to evaluate olfactory, taste (intra-nasal and oral) trigeminal functions in patients with Sjogren's syndrome compared to patients without sicca syndrome.

Conditions

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Sjogren's Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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group 1: patients with Sjogren's syndrome

Patients with Sjogren's syndrome

Group Type OTHER

Evaluation of olfactory function

Intervention Type OTHER

Evaluation of olfactory function using olfactory detection thresholds

Evaluation of taste function

Intervention Type OTHER

Evaluation of taste function using taste detection thresholds

Evaluation of (intra-nasal and oral) trigeminal functions

Intervention Type OTHER

Evaluation of (intra-nasal and oral) trigeminal, interacting with olfactory and taste pathways, using odor and taste stimuli.

group 2: patients without sicca syndrome

Patients without sicca syndrome

Group Type OTHER

Evaluation of olfactory function

Intervention Type OTHER

Evaluation of olfactory function using olfactory detection thresholds

Evaluation of taste function

Intervention Type OTHER

Evaluation of taste function using taste detection thresholds

Evaluation of (intra-nasal and oral) trigeminal functions

Intervention Type OTHER

Evaluation of (intra-nasal and oral) trigeminal, interacting with olfactory and taste pathways, using odor and taste stimuli.

Interventions

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Evaluation of olfactory function

Evaluation of olfactory function using olfactory detection thresholds

Intervention Type OTHER

Evaluation of taste function

Evaluation of taste function using taste detection thresholds

Intervention Type OTHER

Evaluation of (intra-nasal and oral) trigeminal functions

Evaluation of (intra-nasal and oral) trigeminal, interacting with olfactory and taste pathways, using odor and taste stimuli.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* group 1 : patients with Sjogren's syndrome
* group 2: patients without sicca syndrome
* older than 18 years old
* consenting to participate to the study

Exclusion Criteria

* smoking patients
* patients with stomatitis
* patients with upper respiratory tract infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Reims Champagne-Ardenne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clovis FOGUEM, MD

Role: PRINCIPAL_INVESTIGATOR

Université de Reims Champagne-Ardenne

Locations

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Université de Reims Champagne-Ardenne

Reims, , France

Site Status

Countries

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France

Central Contacts

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Clovis FOGUEM, MD

Role: CONTACT

03 26 58 71 45

Other Identifiers

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2021-007-TOG_SJOGREN

Identifier Type: -

Identifier Source: org_study_id

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