Condition category
Digestive System
Date applied
25/07/2012
Date assigned
30/07/2012
Last edited
08/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Reduced salivation (dry mouth) is a common complaint of individuals with Sjogren’s 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 boxer’s 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 Sjogren’s 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

Contact information

Type

Scientific

Primary contact

Dr Stefano Fedele

ORCID ID

Contact details

Eastman Dental Hospital
256 Gray's Inn Road
London
WC1X 8LD
United Kingdom

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 measures

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

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

http://www.uclh.org/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/08/2016: No publications found, verifying study status with principal investigator.