SALivary electro-stimulation for the treatment of dry mouth in patients with Sjogren's syndrome: a multicentRe randomISEd sham-controlled double-blind study (SALRISE)

Disease - Sjögren’s syndrome

Lead applicant - Dr Stefano Fedele

Organisation - University College London

Type of grant - Clinical Studies

Status of grant - Active

Amount of the original award - £439,813.75

Start date - 1 April 2017

Reference - 21233

Public Summary

What are the aims of this research?

Dry mouth is a common symptom of Sjögren’s syndrome. It can compromise speech, swallowing, oral health and general quality of life. This study aims to establish whether electrostimulation of the salivary glands using a small electronic device can be used to treat dry mouth in people with Sjögren’s syndrome.

Why is this research important?

There is currently no effective treatment available for dry mouth, despite both doctors and people with Sjögren’s syndrome listing tackling dry mouth as a core therapeutic goal for Sjögren’s syndrome management. Previous work has shown that stimulating salivary glands using electricity can increase salivation, but it is unknown whether this could cure dry mouth. This group want to test whether a small electronic device, coined a “salivary pacemaker”, can lessen dry mouth symptoms and in turn improve the quality of life of people with Sjögren’s syndrome. They will also calculate whether it is cost effective for the NHS to implement.

How will the findings benefit patients?

Dry mouth is an unmet clinical need highlighted by people with Sjögren’s syndrome, tackling it would massively improve quality of life. These studies are crucial for assessing whether electrostimulation is an effective and viable therapy for dry mouth that the NHS could offer to people with Sjögren’s syndrome. As a non-pharmacological approach with no history of toxicity, if effective, this intervention could be available to people experiencing dry mouth fairly rapidly and safely.