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Olfactory and Taste Disturbances in Sjogren's Syndrome

Olfactory and Taste Disturbances in Sjogren's Syndrome

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04909112
Acronym
TOG_SJOGREN
Enrollment
120
Registered
2021-06-01
Start date
2022-07-01
Completion date
2022-10-01
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjogren's Syndrome

Keywords

Sjogren's syndrome, olfactory disorder, taste disorder, (intra-nasal and oral) trigeminal impairments

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.

Interventions

OTHEREvaluation of olfactory function

Evaluation of olfactory function using olfactory detection thresholds

OTHEREvaluation of taste function

Evaluation of taste function using taste detection thresholds

OTHEREvaluation 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.

Sponsors

Université de Reims Champagne-Ardenne
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Olfactory detection thresholds for Phenyl-ethyl alcoholDay 0Successive 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 ButanolDay 0Successive 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 PyridineDay 0Successive 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

MeasureTime frameDescription
Taste detection thresholds for bitter tasteDay 0Taste 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 tasteDay 0Taste 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 stimuliDay 0Taste 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 tasteDay 0Taste 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 tasteDay 0Taste 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.

Countries

France

Contacts

Primary ContactClovis FOGUEM, MD
Clovis.foguem@chu-reims.fr03 26 58 71 45

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026