Olfactory and Taste Disturbances in Sjogren's Syndrome
TOG_SJOGREN
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2021
CompletedFirst Posted
Study publicly available on registry
June 1, 2021
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMay 25, 2022
May 1, 2022
Same day
May 26, 2021
May 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (5)
Taste detection thresholds for salty taste
Day 0
Taste detection thresholds for sweet taste
Day 0
Taste detection thresholds for sour taste
Day 0
Taste detection thresholds for bitter taste
Day 0
Taste detection thresholds for trigeminal stimuli
Day 0
Study Arms (2)
group 1: patients with Sjogren's syndrome
OTHERPatients with Sjogren's syndrome
group 2: patients without sicca syndrome
OTHERPatients without sicca syndrome
Interventions
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.
Eligibility Criteria
You may qualify if:
- group 1 : patients with Sjogren's syndrome
- group 2: patients without sicca syndrome
- older than 18 years old
- consenting to participate to the study
You may not qualify if:
- smoking patients
- patients with stomatitis
- patients with upper respiratory tract infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Université de Reims Champagne-Ardenne
Reims, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clovis FOGUEM, MD
Université de Reims Champagne-Ardenne
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2021
First Posted
June 1, 2021
Study Start
July 1, 2022
Primary Completion
July 1, 2022
Study Completion
October 1, 2022
Last Updated
May 25, 2022
Record last verified: 2022-05