Clinical trial NCT04178616: Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma
Official title: Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Olfactory Disorders
Scleroderma
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is single-group epidemiologic study, without any control group.
Primary purpose: DIAGNOSTIC

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


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...)

Primary outcomes:
measure: Percentage of patient with hyposmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to 27 points
timeFrame: once time, Baseline
Secondary outcomes:
measure: Percentage of patient with anosmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to10 points
timeFrame: once time, Baseline
measure: Percentage of patients with an unilateral Lund Kennedy score of more than 3 points.
timeFrame: once time, Baseline
measure: Measurement of systemic sclerosis disease activity with Medsger Score
timeFrame: once time, Baseline
measure: Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Medsger Score
timeFrame: once time, Baseline
measure: Correlation between global olfactory score measured with ETOC score and skin involvement severity measured with Rodnan score.
timeFrame: once time, Baseline
measure: Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Health Assessment Questionnaire (HAQ) score
timeFrame: once time, Baseline
measure: Correlation between global olfactory score measured with ETOC score and the rhinologic quality of life score measured with the sinonasal outcome test 22)
timeFrame: once time, Baseline
measure: Correlation between global olfactory score measured with ETOC and Hospital anxiety and Depression (HAD) scale.
timeFrame: once time, Baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: David Launay, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amital H, Agmon-Levin N, Shoenfeld N, Arnson Y, Amital D, Langevitz P, Balbir Gurman A, Shoenfeld Y. Olfactory impairment in patients with the fibromyalgia syndrome and systemic sclerosis. Immunol Res. 2014 Dec;60(2-3):201-7. doi: 10.1007/s12026-014-8573-5.
citation: Bombini MF, Peres FA, Lapa AT, Sinicato NA, Quental BR, Pincelli ASM, Amaral TN, Gomes CC, Del Rio AP, Marques-Neto JF, Costallat LTL, Fernandes PT, Cendes F, Rittner L, Appenzeller S. Olfactory function in systemic lupus erythematosus and systemic sclerosis. A longitudinal study and review of the literature. Autoimmun Rev. 2018 Apr;17(4):405-412. doi: 10.1016/j.autrev.2018.02.002. Epub 2018 Feb 11.