Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma

Study Overview
=================
Brief Summary
-----------------
Prospective monocentric study of patients with systemic sclerosis disease. The primary outcome is to define the prevalence of olfactory disorders (hyposmia and anosmia) in systemic sclerosis disease. The secondary outcomes are: To assess the correlation of olfaction disorders with clinical and biological and factors related to systemic sclerosis patients. To estimate the frequency of sinonasal disorders in patients with systemic sclerosis disease

Official Title
-----------------
Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma

Conditions
-----------------
Olfactory Disorders, Scleroderma

Intervention / Treatment
-----------------
* Diagnostic Test: olfactory testing with specific odorants (localisation and identification)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and/or women With systemic sclerosis disease Patient willing to comply with all procedures of the study and its duration Social insured patients Exclusion Criteria : Patient with medical history of chronic rhinosinusitis (CRS), previously known for olfactory disorders secondary to another etiology (skull base trauma, viral rhinosinusitis) Past history of sinonasal surgery Patient unable to receive informed information Refusal to sign the consent form Unwillingness or inability to follow the study procedures, in the opinion of the investigator Person deprived of the liberty Non-coverage by the social security insurance Person benefiting from a system of legal protection (guardianship…)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: The study is single-group epidemiologic study, without any control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: systemic sclerosis patients population<br>All the patients with systemic sclerosis disease followed in day-care in a tertiary hospital are eligible to be enrolled in the study. | Diagnostic Test: olfactory testing with specific odorants (localisation and identification)<br>* Olfactory testing : ETOC (European Test of Olfactory capabilities)<br>* Other names: nasofibroscopy to identify sinonasal mucosa diseases;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patient with hyposmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to 27 points | The European Test of Olfactory Capabilities is an olfactory test based on standardized odorants.A composite score evaluates the ability of the patients to define odors localisation and odors identification.The maximum global score is 32 points, the minimum is 0 point. The localisation ability score is rated from 0 to 16 points; The identification score is rated from 0 to 16 points. An hyposmia is defined by a global score strictly inferior to 27 points. | once time, Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patient with anosmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to10 points | The European Test of Olfactory Capabilities is an olfactory test based on standardized odorants. A composite score evaluates the ability of the patients to define odors localisation and odors identification. The maximum global score is 32 points, the minimum is 0 point. The localisation ability score is rated from 0 to 16 points; The identification score is rated from 0 to 16 points. An anosmia is defined by an global score strictly inferior to 10 points. | once time, Baseline | 
| Percentage of patients with an unilateral Lund Kennedy score of more than 3 points. | Evaluation of nasal mucosa inflammation status is based on Lund-Kennedy endoscopic score. The Lund Kennedy score ranged from 0 to 8 points for each nasal fossa. It evaluates oedema, discharge, the presence of polyps and crusting, that can be seen through nasal fibroscopy. A score strictly under 3 points on each side is considered as non pathologic whereas a score equal or over 3 points on each side is pathological. A higher score means a worse outcome. | once time, Baseline | 
| Measurement of systemic sclerosis disease activity with Medsger Score | Medsger Score estimates disease involvement of each organ (heart, vessels, skin, brain, kidney, gut, muscle, joint and loss of weight,) ranging from 0 to 4 (0: normal, 1: mild, 2: moderate, 3: severe, 4: terminal). The score ranges from 0 to 36 points.A higher score means a worse outcome. | once time, Baseline | 
| Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Medsger Score | The ETOC score ranges from 0 to 32 points ( as previously described ).A higher score means a better outcome. Medsger score ranges from 0 to 36 points. A higher score means a worse outcome. | once time, Baseline | 
| Correlation between global olfactory score measured with ETOC score and skin involvement severity measured with Rodnan score. | The ETOC score ranges from 0 to 32 points ( as previously described ). A higher score means a better outcome. The Rodnan score measured skin thickness (0 : normal, 1 : mild, 2: moderate, 3: severe) on 17 different sites. A global score between 0 point to 51 points is established.A higher score means a worse outcome | once time, Baseline | 
| Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Health Assessment Questionnaire (HAQ) score | The ETOC score ranges from 0 to 32 points (as previously described ). A higher score means a better outcome. The Health Assessment Questionnaire is based on 20 questions related to routine activities with a grading system ranging from 0 to 3 (0: no difficulty, 1: moderate difficulty, 2: severe difficulty, 3: total incapacity). A global score between 0 point to 60 points is established. a higher HAQ score means a worse outcome | once time, Baseline | 
| Correlation between global olfactory score measured with ETOC score and the rhinologic quality of life score measured with the sinonasal outcome test 22) | The ETOC score ranges from 0 to 32 points ( as previously described ). A higher score means a better outcome. The sinonasal outcome test 22 is based on 22 questions with a grading from 0 to 5 ( 0: no probem, 1: very mild problem, 2: mild problem, 3: moderate problem, 4: severe problem, 5: very severe problem). A global score between 0 and 110 points is measured. A higher score means a worse outcome. | once time, Baseline | 
| Correlation between global olfactory score measured with ETOC and Hospital anxiety and Depression (HAD) scale. | The ETOC score ranges from 0 to 32 points ( as previously described ). A higher score means a better outcome. The Hospital anxiety and Depression (HAD) scale is based on 14 questions with a grading system ranging from 0 to 3. A global score between 0 and 42 is measured. A higher score means a worse outcome. | once time, Baseline |