Using a smartphone app to track symptoms in burning mouth syndrome patients
FIRE Trial: Reducing Patient Memory Recall in the Burning Mouth Patient Population
This study is testing a smartphone app to help people with burning mouth syndrome track their symptoms and saliva changes over 12 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05819697 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand the symptoms of burning mouth syndrome (BMS) in real time by utilizing a smartphone app. Participants will complete questionnaires and provide saliva samples during two study visits, while also responding to notifications three times a day for 12 weeks. The study will assess fluctuations in BMS symptoms and evaluate salivary biomarkers to better characterize the condition. The collaboration between Penn Dental Medicine and the Wharton School of Business seeks to enhance data collection and analysis through innovative technology.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 and older who have been diagnosed with burning mouth syndrome for at least three months and have access to a smartphone.
Not a fit: Patients with cognitive or physical impairments, prior head and neck radiation or chemotherapy, or those on medications that affect the inflammatory system may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of burning mouth syndrome symptoms for patients.
How similar studies have performed: While the use of smartphone apps for symptom tracking is becoming more common, this specific approach to studying burning mouth syndrome is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Individuals aged 18 years and older 2. Willing and able to provide informed consent 3. Have been diagnosed with BMS for at least three months by an Oral Medicine or other specialist 4. Willing to submit a saliva sample 5. Have continuous access to a smartphone Exclusion criteria: 1. In the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason (e.g. cognitive or physical impairment) 2. Prior head and neck radiation and/or chemotherapy 3. Medications that modulate or suppress the inflammatory system
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Eugene Ko, DDS — Penn Dental School of Medicine, Center for Clinical and Translational Research
- Study coordinator: Eugene Ko, DDS
- Email: PDMTranslationalMed@dental.upenn.edu
- Phone: 215-573-8177
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.