Sjogren's SyndromeTOG_SJOGRENNCT04909112
Olfactory and Taste Disturbances in Sjogren's Syndrome
A study testing Evaluation of olfactory function, Evaluation of taste function and Evaluation of (intra-nasal and oral) trigeminal functions in people with Sjogren's Syndrome, run by Université de Reims Champagne-Ardenne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- Evaluation of olfactory function, Evaluation of taste function and Evaluation of (intra-nasal and oral) trigeminal functions
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2022to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- group 1 : patients with Sjogren's syndrome
- group 2: patients without sicca syndrome
- older than 18 years old
- consenting to participate to the study
Who cannot join
- smoking patients
- patients with stomatitis
- patients with upper respiratory tract infection
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sjogren's Syndrome
- Being tested
- Evaluation of olfactory function, Evaluation of taste function, Evaluation of (intra-nasal and oral) trigeminal functions
- Keywords
- Sjogren's syndrome, olfactory disorder, taste disorder, (intra-nasal and oral) trigeminal impairments
- Medical subject headings
- Sjogren's Syndrome, Taste Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of olfactory functionOther
Evaluation of olfactory function using olfactory detection thresholds
Evaluation of taste functionOther
Evaluation of taste function using taste detection thresholds
Evaluation of (intra-nasal and oral) trigeminal functionsOther
Evaluation of (intra-nasal and oral) trigeminal, interacting with olfactory and taste pathways, using odor and taste stimuli.
| Study group | Role | What they receive |
|---|---|---|
| group 1: patients with Sjogren's syndrome | Other | Patients with Sjogren's syndrome Receives: Other: Evaluation of olfactory function; Other: Evaluation of taste function; Other: Evaluation of (intra-nasal and oral) trigeminal functions |
| group 2: patients without sicca syndrome | Other | Patients without sicca syndrome Receives: Other: Evaluation of olfactory function; Other: Evaluation of taste function; Other: Evaluation of (intra-nasal and oral) trigeminal functions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 0
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clovis FOGUEM, MD, Principal investigator, Université de Reims Champagne-Ardenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909112
- Sponsor's protocol ID
- 2021-007-TOG_SJOGREN
- Acronym
- TOG_SJOGREN
- Status last verified
- May 2022
- First submitted
- 26 May 2021
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory and Taste Disturbances in Sjogren's Syndrome
- ClinicalTrials.gov ID
- NCT04909112
- Acronym / sponsor ID
- TOG_SJOGREN / 2021-007-TOG_SJOGREN
- Conditions
- Sjogren's Syndrome
- Keywords
- Sjogren's syndrome, olfactory disorder, taste disorder, (intra-nasal and oral) trigeminal impairments
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1: patients with Sjogren's syndrome | Other | Other: Evaluation of olfactory function, Other: Evaluation of taste function, Other: Evaluation of (intra-nasal and oral) trigeminal functionsPatients with Sjogren's syndrome |
| group 2: patients without sicca syndrome | Other | Other: Evaluation of olfactory function, Other: Evaluation of taste function, Other: Evaluation of (intra-nasal and oral) trigeminal functionsPatients without sicca syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- group 1 : patients with Sjogren's syndrome
- group 2: patients without sicca syndrome
- older than 18 years old
- consenting to participate to the study
Key exclusion criteria (3 listed)
- smoking patients
- patients with stomatitis
- patients with upper respiratory tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of olfactory functionEvaluation of olfactory function using olfactory detection thresholds | Other | group 1: patients with Sjogren's syndrome, group 2: patients without sicca syndrome |
| Evaluation of taste functionEvaluation of taste function using taste detection thresholds | Other | group 1: patients with Sjogren's syndrome, group 2: patients without sicca syndrome |
| Evaluation of (intra-nasal and oral) trigeminal functionsEvaluation of (intra-nasal and oral) trigeminal, interacting with olfactory and taste pathways, using odor and taste stimuli. | Other | group 1: patients with Sjogren's syndrome, group 2: patients without sicca syndrome |
Primary outcome
Olfactory detection thresholds for Phenyl-ethyl alcohol
Time frame: 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
Time frame: 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
Time frame: 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.
5 secondary outcomes
Taste detection thresholds for salty taste
Time frame: Day 0
Taste detection thresholds for sweet taste
Time frame: Day 0
Taste detection thresholds for sour taste
Time frame: Day 0
Taste detection thresholds for bitter taste
Time frame: Day 0
Taste detection thresholds for trigeminal stimuli
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clovis FOGUEM, MD principal investigator
Université de Reims Champagne-Ardenne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of olfactory function, Evaluation of taste function and Evaluation of (intra-nasal and oral) trigeminal functions in people with Sjogren's Syndrome, run by Université de Reims Champagne-Ardenne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clovis FOGUEM, MD (03 26 58 71 45, Clovis.foguem@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olfactory detection thresholds for Phenyl-ethyl alcohol (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.