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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sjogren's Syndrome
• Intervention / Treatment: Other: Evaluation of olfactory function; Other: Evaluation of taste function; Other: Evaluation of (intra-nasal and oral) trigeminal functions

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clovis FOGUEM, MD; Phone Number: 03 26 58 71 45; Email: Clovis.foguem@chu-reims.fr

Study Locations

• France
  • Reims, France
    • Université de Reims Champagne-Ardenne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: group 1: patients with Sjogren's syndrome; Patients with Sjogren's syndrome	Other: Evaluation of olfactory function; Evaluation of olfactory function using olfactory detection thresholds; Other: Evaluation of taste function; Evaluation of taste function using taste detection thresholds; 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.
Other: group 2: patients without sicca syndrome; Patients without sicca syndrome	Other: Evaluation of olfactory function; Evaluation of olfactory function using olfactory detection thresholds; Other: Evaluation of taste function; Evaluation of taste function using taste detection thresholds; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Olfactory detection thresholds for Phenyl-ethyl alcohol	Successive dilutions of odorants by a factor 2 will be realized with distilled water as solvent. The odorant stimulus will be presented in a white glass bottle filled with 4 ml of liquid. The bottle will be presented for 3 seconds, medially 1 cm under both nostrils. Odour thresholds will be assessed using an ascending staircase, binary (stimulus vs. blank) forced-choice procedure, with inter-trial intervals of 90 seconds. The two bottles will presented to the subject in random order. After sniffing each stimulus, the participant will be asked to identify the one who smelled stronger. An incorrect choice will led to increase the concentration of the stimulus in the next trial. The dilution step at which the odorant stimulus will be first detected correctly three times in a row will be recorded as the detection threshold.	Day 0
Olfactory detection thresholds for Butanol	Successive dilutions of odorants by a factor 2 will be realized with distilled water as solvent. The odorant stimulus will be presented in a white glass bottle filled with 4 ml of liquid. The bottle will be presented for 3 seconds, medially 1 cm under both nostrils. Odour thresholds will be assessed using an ascending staircase, binary (stimulus vs. blank) forced-choice procedure, with inter-trial intervals of 90 seconds. The two bottles will presented to the subject in random order. After sniffing each stimulus, the participant will be asked to identify the one who smelled stronger. An incorrect choice will led to increase the concentration of the stimulus in the next trial. The dilution step at which the odorant stimulus will be first detected correctly three times in a row will be recorded as the detection threshold.	Day 0
Olfactory detection thresholds for Pyridine	Successive dilutions of odorants by a factor 2 will be realized with distilled water as solvent. The odorant stimulus will be presented in a white glass bottle filled with 4 ml of liquid. The bottle will be presented for 3 seconds, medially 1 cm under both nostrils. Odour thresholds will be assessed using an ascending staircase, binary (stimulus vs. blank) forced-choice procedure, with inter-trial intervals of 90 seconds. The two bottles will presented to the subject in random order. After sniffing each stimulus, the participant will be asked to identify the one who smelled stronger. An incorrect choice will led to increase the concentration of the stimulus in the next trial. The dilution step at which the odorant stimulus will be first detected correctly three times in a row will be recorded as the detection threshold.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Taste detection thresholds for salty taste	Taste strips will be placed on the tongue. Each strip contains a stimulus at different concentrations. Patient will be asked if he/she perceive the taste.	Day 0
Taste detection thresholds for sweet taste	Taste strips will be placed on the tongue. Each strip contains a stimulus at different concentrations. Patient will be asked if he/she perceive the taste.	Day 0
Taste detection thresholds for sour taste	Taste strips will be placed on the tongue. Each strip contains a stimulus at different concentrations. Patient will be asked if he/she perceive the taste.	Day 0
Taste detection thresholds for bitter taste	Taste strips will be placed on the tongue. Each strip contains a stimulus at different concentrations. Patient will be asked if he/she perceive the taste.	Day 0
Taste detection thresholds for trigeminal stimuli	Taste strips will be placed on the tongue. Each strip contains a stimulus at different concentrations. Patient will be asked if he/she perceive the taste.	Day 0

Collaborators and Investigators

• Sponsor: Université de Reims Champagne-Ardenne
• Investigators: Principal Investigator: Clovis FOGUEM, MD, Université de Reims Champagne-Ardenne

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Sjogren's syndrome; taste disorder; olfactory disorder; (intra-nasal and oral) trigeminal impairments
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Neurologic Manifestations; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Sensation Disorders; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Taste Disorders; Syndrome; Sjogren's Syndrome; Dysgeusia
• Other Study ID Numbers: 2021-007-TOG_SJOGREN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No