Olfactory and Taste Disturbances in Sjogren's Syndrome
- Conditions
- Sjogren's Syndrome
- Interventions
- Other: Evaluation of olfactory functionOther: Evaluation of taste functionOther: Evaluation of (intra-nasal and oral) trigeminal functions
- Registration Number
- NCT04909112
- Lead Sponsor
- Université de Reims Champagne-Ardenne
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- group 1 : patients with Sjogren's syndrome
- group 2: patients without sicca syndrome
- older than 18 years old
- consenting to participate to the study
- smoking patients
- patients with stomatitis
- patients with upper respiratory tract infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group 1: patients with Sjogren's syndrome Evaluation of taste function Patients with Sjogren's syndrome group 2: patients without sicca syndrome Evaluation of olfactory function Patients without sicca syndrome group 2: patients without sicca syndrome Evaluation of taste function Patients without sicca syndrome group 2: patients without sicca syndrome Evaluation of (intra-nasal and oral) trigeminal functions Patients without sicca syndrome group 1: patients with Sjogren's syndrome Evaluation of olfactory function Patients with Sjogren's syndrome group 1: patients with Sjogren's syndrome Evaluation of (intra-nasal and oral) trigeminal functions Patients with Sjogren's syndrome
- Primary Outcome Measures
Name Time Method Olfactory detection thresholds for Phenyl-ethyl alcohol Day 0 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.Olfactory detection thresholds for Butanol Day 0 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.Olfactory detection thresholds for Pyridine Day 0 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.
- Secondary Outcome Measures
Name Time Method Taste detection thresholds for bitter taste Day 0 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.
Taste detection thresholds for sour taste Day 0 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.
Taste detection thresholds for salty taste Day 0 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.
Taste detection thresholds for sweet taste Day 0 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.
Taste detection thresholds for trigeminal stimuli Day 0 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.
Trial Locations
- Locations (1)
Université de Reims Champagne-Ardenne
🇫🇷Reims, France