The Effect of Sjögren's Syndrome
Research type
Research Study
Full title
The effect of Sjӧgren’s Syndrome on the senses of smell and taste, and on sexuality in female patients in the UK: Impact on quality of life
IRAS ID
186276
Contact name
Minan Al-Ezzi
Contact email
Sponsor organisation
Queen Mary University of London
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 3 months, 18 days
Research summary
Sjögren’s Syndrome (SS) is the second most common autoimmune rheumatic disease of unknown etiology commonly affecting women with a female to male ratio of 9:1.The hallmark of SS is the production of autoantibodies to exocrine glands, causing oral, nasal, ocular and genital dryness. SS patients frequently report taste and smell impairment and vaginal discomfort that impact on their quality of life (QoL). However, unlike other aspects of this syndrome, these symptoms have not been investigated thoroughly. Objectives: 1.To assess the prevalence of smell and taste impairment in SS patient group. 2.To investigate whether the loss of smell and taste co-occur in SS patients. 3.To relate the degree of loss of smell and taste to the severity of oral dryness. 4. To assess the prevalence of sexual dysfunction in SS patients. 5. To investigate the aetiology of sexual dysfunction in SS patients. 6.To evaluate the effect of smell and taste and sexual health on QoL. Methods: The first stage of the project will be a case-control study to evaluate the prevalence and the significance of smell and taste function in SS patients attending Barts Health Trust. In this stage, the study subjects and controls will undergo the same testing procedures (testing for the acuity of the senses of smell & taste, the severity of mouth dryness and filling out 5 questionnaires to assess the quality of life (QoL). It is envisaged that the results of the first stage of the study will help support a future qualitative research (Second Stage), to investigate the sexual dysfunction in SS patients, and to get an insight into the coping mechanism of SS patients with the sexual dysfunction. This will be performed by applying a separate protocol and a separate application form. This project will provide important information from a patient-centered perspective and help inform clinicians and researchers to develop an evidence-based care package for SS patients. This is a PhD project at Queen Mary University of London.
REC name
London - London Bridge Research Ethics Committee
REC reference
15/LO/2064
Date of REC Opinion
10 Feb 2016
REC opinion
Further Information Favourable Opinion