Olfactory and Taste Disturbances in Sjogren's Syndrome

Study Overview
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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.

Official Title
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Olfactory and Taste Disturbances in Sjogren's Syndrome

Conditions
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Sjogren's Syndrome

Intervention / Treatment
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* Other: Evaluation of olfactory function
* Other: Evaluation of taste function
* Other: Evaluation of (intra-nasal and oral) trigeminal functions


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: group 1: patients with Sjogren's syndrome<br>Patients with Sjogren's syndrome | Other: Evaluation of olfactory function<br>* Evaluation of olfactory function using olfactory detection thresholds<br>Other: Evaluation of taste function<br>* Evaluation of taste function using taste detection thresholds<br>Other: Evaluation of (intra-nasal and oral) trigeminal functions<br>* Evaluation of (intra-nasal and oral) trigeminal, interacting with olfactory and taste pathways, using odor and taste stimuli.<br>|
| Other: group 2: patients without sicca syndrome<br>Patients without sicca syndrome | Other: Evaluation of olfactory function<br>* Evaluation of olfactory function using olfactory detection thresholds<br>Other: Evaluation of taste function<br>* Evaluation of taste function using taste detection thresholds<br>Other: Evaluation of (intra-nasal and oral) trigeminal functions<br>* Evaluation of (intra-nasal and oral) trigeminal, interacting with olfactory and taste pathways, using odor and taste stimuli.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sjogren's syndrome, olfactory disorder, taste disorder, (intra-nasal and oral) trigeminal impairments