Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma (SCLEROLF)

University Hospital, Lille

Status: Terminated

Conditions: Olfactory Disorders; Scleroderma

Treatments: Diagnostic Test: olfactory testing with specific odorants (localisation and identification)

Study type: Interventional

Funder types: Other

Identifiers

NCT04178616

2019-A01083-54 (Other Identifier)

2018_84

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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...)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

systemic sclerosis patients population

Other group

Description:

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

Treatment:

Diagnostic Test: olfactory testing with specific odorants (localisation and identification)