Olfactory and Taste Disturbances in Sjogren's Syndrome

Sjogren's Syndrome Clinical Trial

— TOG_SJOGREN  

Official title:

Olfactory and Taste Disturbances in Sjogren's Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04909112
• Other study ID #: 2021-007-TOG_SJOGREN
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: May 2022
• Source: Université de Reims Champagne-Ardenne
• Contact: Clovis FOGUEM, MD
• Phone: 03 26 58 71 45
• Email: Clovis.foguem[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysgeusia
• Sjogren's Syndrome
• Syndrome

Intervention

Other:
• Evaluation of olfactory function
Evaluation of olfactory function using olfactory detection thresholds
• Evaluation of taste function
Evaluation of taste function using taste detection thresholds
• 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.

Locations

Country	Name	City	State
France	Université de Reims Champagne-Ardenne	Reims

Sponsors (1)

Lead Sponsor	Collaborator
Université de Reims Champagne-Ardenne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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