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Olfactory and Taste Disturbances in Sjogren's Syndrome (TOG_SJOGREN)

Primary Purpose

Sjogren's Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluation of olfactory function
Evaluation of taste function
Evaluation of (intra-nasal and oral) trigeminal functions
Sponsored by
Université de Reims Champagne-Ardenne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sjogren's Syndrome focused on measuring Sjogren's syndrome, olfactory disorder, taste disorder, (intra-nasal and oral) trigeminal impairments

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Université de Reims Champagne-Ardenne

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

group 1: patients with Sjogren's syndrome

group 2: patients without sicca syndrome

Arm Description

Patients with Sjogren's syndrome

Patients without sicca syndrome

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
May 26, 2021
Last Updated
May 24, 2022
Sponsor
Université de Reims Champagne-Ardenne
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1. Study Identification

Unique Protocol Identification Number
NCT04909112
Brief Title
Olfactory and Taste Disturbances in Sjogren's Syndrome
Acronym
TOG_SJOGREN
Official Title
Olfactory and Taste Disturbances in Sjogren's Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Reims Champagne-Ardenne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjogren's Syndrome
Keywords
Sjogren's syndrome, olfactory disorder, taste disorder, (intra-nasal and oral) trigeminal impairments

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1: patients with Sjogren's syndrome
Arm Type
Other
Arm Description
Patients with Sjogren's syndrome
Arm Title
group 2: patients without sicca syndrome
Arm Type
Other
Arm Description
Patients without sicca syndrome
Intervention Type
Other
Intervention Name(s)
Evaluation of olfactory function
Intervention Description
Evaluation of olfactory function using olfactory detection thresholds
Intervention Type
Other
Intervention Name(s)
Evaluation of taste function
Intervention Description
Evaluation of taste function using taste detection thresholds
Intervention Type
Other
Intervention Name(s)
Evaluation of (intra-nasal and oral) trigeminal functions
Intervention Description
Evaluation of (intra-nasal and oral) trigeminal, interacting with olfactory and taste pathways, using odor and taste stimuli.
Primary Outcome Measure Information:
Title
Olfactory detection thresholds for Phenyl-ethyl alcohol
Description
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
Title
Olfactory detection thresholds for Butanol
Description
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
Title
Olfactory detection thresholds for Pyridine
Description
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
Secondary Outcome Measure Information:
Title
Taste detection thresholds for salty taste
Description
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
Title
Taste detection thresholds for sweet taste
Description
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
Title
Taste detection thresholds for sour taste
Description
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
Title
Taste detection thresholds for bitter taste
Description
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
Title
Taste detection thresholds for trigeminal stimuli
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clovis FOGUEM, MD
Phone
03 26 58 71 45
Email
Clovis.foguem@chu-reims.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clovis FOGUEM, MD
Organizational Affiliation
Université de Reims Champagne-Ardenne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université de Reims Champagne-Ardenne
City
Reims
Country
France

12. IPD Sharing Statement

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Olfactory and Taste Disturbances in Sjogren's Syndrome

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