An interventional study of Evaluation of olfactory function and Evaluation of taste function in Sjogren's Syndrome, sponsored by Université de Reims Champagne-Ardenne. Status unknown at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-25.
Sponsored by Université de Reims Champagne-Ardenne · Not applicable, Interventional, and Basic science
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.
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.
330 studies on the registry are indexed under Sjogren's Syndrome; 99 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 218 interventional studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →Université de Reims Champagne-Ardenne is the lead sponsor of 64 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Patients with Sjogren's syndrome
Other: Evaluation of olfactory function · Other: Evaluation of taste function · Other: Evaluation of (intra-nasal and oral) trigeminal functions
Patients without sicca syndrome
Other: Evaluation of olfactory function · Other: Evaluation of taste function · Other: Evaluation of (intra-nasal and oral) trigeminal functions
Evaluation of olfactory function using olfactory detection thresholds
Evaluation of taste function using taste detection thresholds
Evaluation of (intra-nasal and oral) trigeminal, interacting with olfactory and taste pathways, using odor and taste stimuli.
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0
Start is estimated for Jul 2022; primary completion for Jul 2022, 0 months later.
Of 39 non-industry interventional studies with no phase under Sjogren's Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's planned 0 months is below that.
Counting every sponsor, half of 44 studies reached it within 18 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Université de Reims Champagne-Ardenne