Olfactory and Taste Disturbances in Sjogren's Syndrome (TOG_SJOGREN)

Université de Reims Champagne-Ardenne

Status: Unknown

Conditions: Sjogren's Syndrome

Treatments: Other: Evaluation of olfactory function; Other: Evaluation of taste function; Other: Evaluation of (intra-nasal and oral) trigeminal functions

Study type: Interventional

Funder types: Other

Identifiers

NCT04909112

2021-007-TOG_SJOGREN

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

group 1: patients with Sjogren's syndrome

Other group

Description:

Patients with Sjogren's syndrome

Treatment:

Other: Evaluation of taste function

Other: Evaluation of (intra-nasal and oral) trigeminal functions

Other: Evaluation of olfactory function

group 2: patients without sicca syndrome

Other group

Description:

Patients without sicca syndrome

Treatment:

Other: Evaluation of taste function

Other: Evaluation of (intra-nasal and oral) trigeminal functions

Other: Evaluation of olfactory function