Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 13, 2020

Interventions

  • Diagnostic Test: olfactory testing with specific odorants (localisation and identification)
    • Olfactory testing : ETOC (European Test of Olfactory capabilities)

Arms, Groups and Cohorts

  • Other: systemic sclerosis patients population
    • All the patients with systemic sclerosis disease followed in day-care in a tertiary hospital are eligible to be enrolled in the study.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of patient with hyposmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to 27 points
    • Time Frame: once time, Baseline
    • 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.

Secondary Measures

  • Percentage of patient with anosmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to10 points
    • Time Frame: once time, Baseline
    • 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.
  • Percentage of patients with an unilateral Lund Kennedy score of more than 3 points.
    • Time Frame: once time, Baseline
    • 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.
  • Measurement of systemic sclerosis disease activity with Medsger Score
    • Time Frame: once time, Baseline
    • 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.
  • Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Medsger Score
    • Time Frame: once time, Baseline
    • 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.
  • Correlation between global olfactory score measured with ETOC score and skin involvement severity measured with Rodnan score.
    • Time Frame: once time, Baseline
    • 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
  • Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Health Assessment Questionnaire (HAQ) score
    • Time Frame: once time, Baseline
    • 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
  • Correlation between global olfactory score measured with ETOC score and the rhinologic quality of life score measured with the sinonasal outcome test 22)
    • Time Frame: once time, Baseline
    • 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.
  • Correlation between global olfactory score measured with ETOC and Hospital anxiety and Depression (HAD) scale.
    • Time Frame: once time, Baseline
    • 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.

Participating in This Clinical Trial

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…)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Lille
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Launay, MD,PhD, Principal Investigator, University Hospital, Lille

References

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.

Citations Reporting on Results

Bombini MF, Peres FA, Lapa AT, Sinicato NA, Quental BR, Pincelli ÁSM, 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. Review.

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