Plain English Summary
Background and study aims
Reduced salivation (dry mouth) is a common complaint of individuals with Sjogrens syndrome. It is a distressing condition which can lead to long-lasting oral discomfort, dental infections, diminished quality of life, social isolation and loneliness. As current treatments for dry mouth are often unsatisfactory, expensive and may result in adverse effects, further research in this area is needed. A new electronic device has recently been developed to treat dry mouth. The device, acting as a salivary pacemaker, is applied into the mouth (similar to a boxers mouthguard) for a few minutes, harmlessly stimulates the nerves of the salivary glands (salivary electrostimulation) and does not cause adverse side effects. The aim of this study is to assess the effectiveness of the device in patients with Sjogrens syndrome to demonstrate whether using it daily is an effective treatment for dry mouth. The present study will pave the way for a future large study with a view to provide, for the first time, data regarding the long-term effectiveness of salivary electrostimulation.
Who can participate?
Individuals over 18 years of age who have been diagnosed with primary Sjogren's syndrome.
What does the study involve?
Participants will be randomly allocated to either receive the actual device or a sham device that will not deliver electric stimuli but only tactile stimulation (like using chewing gum). Participants will use the device for 6 months after receiving appropriate instructions, and will be allowed to continue using their routine local therapy for dry mouth (e.g. artificial saliva or sipping water) during the study. Participants will also be asked to attend hospital appointments to measure changes in saliva production and complete questionnaires on their dry mouth sensation. Each participant will keep a home diary of their frequency of use and any changes in dry mouth sensation.
What are the possible benefits and risks for participants?
Apart from helping medical research, study participants will benefit from using a new medication-free treatment that based on previous research - is likely to lessen their dry mouth sensation. No significant risk is expected.
Where is the study run from?
University College London Hospital (lead centre) and Birmingham Dental Hospital.
When is study starting and how long is it expected to run for?
Recruitment started in March 2012 and is expected to close in March 2013.
Who is funding the study?
The study is sponsored by University College London Hospital Trust and funded by Arthritis Research UK.
Who is the main contact?
Stefano Fedele
s.fedele@ucl.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
11543
Study information
Scientific title
Long-term effectiveness of a novel intra-oral electro-stimulator for the treatment of dry mouth in patients with Sjogren's syndrome: a feasibility study
Acronym
LEONIDAS-1
Study hypothesis
A novel electronic device that goes in the mouth (intraoral) has been recently developed to treat dry mouth (xerostomia). The device, acting as a salivary pacemaker, is suggested to harmlessly stimulate nerves of the salivary glands without side effects. The aim of this feasibility study is to test the device on a small group of patients with Sjogren's syndrome (SS) in order to define the most appropriate research design of a future large multi-centre study.
Ethics approval
NRES Committee Yorkshire & The Humber - Sheffield, 13/01/2012, ref: 11/YH/0423
Study design
Randomised interventional pilot trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Oral, gastrointestinal and dental
Intervention
Electrostimulation, Intra-oral electrostimulating device (salivary pacemaker)
Intervention type
Device
Phase
Drug names
Primary outcome measure
Reduction in dry mouth symptoms measured at 1, 2, 4, 5 months
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/03/2012
Overall trial end date
30/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Be at least 18 years of age
2. Have clinical symptoms of xerostomia (dry mouth) due to primary SS syndrome diagnosed on the basis of 2001 EUUSA classification criteria
3. Degree of dry mouth symptoms: a minimum degree of dryness of 50mm (=50mm) on a 100mm VAS scale (0= no dryness; 100 = maximum dryness)
4. NO systemic sialogogue therapy (e.g. pilocarpine) for the duration of the study
5. Female patients of child bearing potential must have a negative pregnancy test within twenty-four hours of enrolment
6. To understand and consent in writing to the procedure
7. To agree to undergo all the examinations and clinical evaluations of the study
8. To have evidence of residual salivary gland function, by demonstrating an increase in salivary flow on appropriate stimulation e.g. citric acid stimulation or chewing paraffin wax)
9. To have unstimulated whole salivary flow higher than 0 ml/15min (unstimulated salivary flow as measured via sialometry for 15 minutes)
10. Male and female particioants
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 30; UK Sample Size: 30
Participant exclusion criteria
1. Severe systemic disease (on the basis of the classification of the American Society of Anesthesiology: ASAIII and ASA IV)
2. Known allergy to materials similar to those used in the investigational product
3. To wear other active implants such as cardiac pacemaker or defibrillator, or hearing aids
4. Complete lower edentulous status (i.e. possess no lower teeth)
5. To have oral anatomical or disease-related characteristics that preclude the insertion of the device (e.g. mandibular torus, severe trismus)
6. To be unable or unwilling to cooperate with study procedures
7. To have evidence of no residual salivary gland function (via citric acid stimulation or chewing paraffin wax test)
8. To have an unstimulated whole salivary flow = 0 ml/15min (Absence of unstimulated salivary flow as measured via sialometry for 15 minutes)
Recruitment start date
01/03/2012
Recruitment end date
30/06/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Eastman Dental Hospital
London
WC1X 8LD
United Kingdom
Sponsor information
Organisation
University College London Hospitals NHS Foundation Trust (UK)
Sponsor details
The Hatter Institute for Cardiovascular Studies
25 Grafton Way
London
WC1E 6DB
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Arthritis Research UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list