Salivary electro-stimulation for the treatment of dry mouth in patients with Sjogren's syndrome
- Conditions
- Primary Sjogren’s syndromeOral HealthSicca syndrome
- Registration Number
- ISRCTN52105758
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 136
1. Patients aged =18 years at the time of signing the Informed Consent Form
2. Patients with diagnosis of primary Sjögren’s syndrome (pSS) according to 2002 EU/US or 2016 ACR/EULAR classification criteria
3. Symptomatic oral dryness (>5/10 on patient-completed Numerical Rating Scale)
4. Evidence of residual salivary gland function, demonstrated by an increase in salivary flow on appropriate stimulation (e.g. chewing paraffin wax) as compared to the unstimulated salivary flow
5. Unstimulated whole salivary flow higher than 0 ml/5min (unstimulated whole salivary flow as measured via sialometry for 5 minutes)
6. Patient has provided written informed consent
1. Patient has a cardiac pacemaker or other implanted electrostimulating device fitted, e.g. deep brain stimulation device, a cardiac defibrillator
2. Patient has epileptic disorder, essential tremor, involuntary muscle movement disorder, e.g. Parkinson’s disease or trigeminal neuralgia
3. Patient has evidence of chronic erosive/ulcerative disease or chronic keratotic disorders of the oral mucosa (e.g. lichen planus) or jaw osteonecrosis upon oral examination
4. Patient has suspected or confirmed malignant disease or pre-malignancy (dysplasia) of the oral mucosa
5. Patient has active malignancy (any organ other than the oral mucosa)
6. Current pregnancy as confirmed by urine pregnancy test at Eligibility and Baseline Assessment visit
7. Pilocarpine therapy during the 14 days prior to the Eligibility and Baseline Assessment visit
8. Concomitant use of systemic sialogogue therapy (e.g. pilocarpine) throughout the study
9. Unstable dose over the 4 weeks prior to the Eligibility and Baseline Assessment visit of any medication or therapy known to have an effect upon saliva production (or 7 days in the case of antihistamines)
10. Patient has received a rituximab infusion within the 6 months prior to the Eligibility and Baseline Assessment visit
11. Patient has received acupuncture for the dry mouth symptoms of pSS within the 28 days prior to the Eligibility and Baseline Assessment visit
12. Patient previously participated in LEONIDAS-1, already owns a SaliPen device, any of the earlier generations of the device or any other device with a similar electrostimulatory mode of action that acts upon the salivary glands.
13. Expected non-compliance with treatment interventions or is considered unsuitable for trial participation at the discretion of the treating clinician/nurse
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Xerostomia Inventory [XI] score, a validated patient-centred functional outcome measure for xerostomia; Timepoint(s): 52 weeks post randomisation
- Secondary Outcome Measures
Name Time Method <br> 1. Longitudinal XI score over 52 weeks<br> 2. Stimulated and unstimulated whole salivary flow to measure salivary gland function over 52 weeks<br> 3. Dry mouth symptoms measured using 0-100 mm VAS over 52 weeks<br> 4. Dry mouth symptoms measured using five-point Likert scale of change in dry mouth severity over 52 weeks (much worse, worse, the same, better and much better)<br> 5. Frequency of device use per day using participant-reported daily diaries over 52 weeks<br> 6. Oral health-related QoL measured using the Oral Health Impact Profile-14 (OHIP-14) over 52 weeks<br> 7. Incremental cost effectiveness of the SaliPen salivary electrostimulating device and sham device over 52 weeks<br> 8. Adverse events and serious adverse events relating to the trial device or oral symptoms of pSS reported over 52 weeks<br>