Reducing Patient Memory Recall in the Burning Mouth Patient Population
ConditionBurning Mouth Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
The goal of this study is to learn about burning mouth syndrome symptoms in real time in patients with burning mouth syndrome. The main questions it aims to answer are:
(1) To test the ability of a smartphone app to collect repeated observations of individual data to assess fluctuations in BMS symptoms (pain) at multiple points in the day as they happen; (2) To evaluate a panel of salivary biomarkers in patients with burning mouth syndrome (BMS) and to study their relationship with clinical variables. With a collaboration between Penn Dental Medicine and Wharton School of Business, our proposal aims to vastly improve the characterization of burning mouth syndrome through the use of a smartphone app and/or text-based notification.
Participants will attend 2 study visits where they will complete questionnaires and provide saliva samples and will respond to notifications/text message prompts on their smart phone 3 times a day for 12 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals aged 18 years and older
Willing and able to provide informed consent
Have been diagnosed with BMS for at least three months by an Oral Medicine or other specialist
Willing to submit a saliva sample
Disqualifiers
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)
Prior head and neck radiation and/or chemotherapy
Medications that modulate or suppress the inflammatory system
Trial population
The target population will be patients who have been diagnosed with burning mouth syndrome by Oral Medicine specialists.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
FIRE Trial/Track Your Happiness notifications
Other interventionAll participants will receive notifications to their smart phones 3 times a day for 12 weeks. They will be asked questions related to burning mouth, to exercise as well as non-clinical Track Your Happiness questions, e.g., "Are you interacting with anyone right now?" "How do you feel right now?"
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: FIRE Trial Participants1 intervention
Trial outcomes
Primary outcomes
1
Track Your Happiness App utilization for Burning Mouth Syndrome (BMS) symptom reports in real time
Track Your Happiness app on smartphone and/or text base notification system will collect data in real time on people's experiences across a random sample of the moments of their lives through surveys. Participants will receive a notification on their phone at three random times each day and be prompted to answer questions adapted from the FIRE questionnaire related to burning mouth syndrome symptoms.
Time frame
12 weeksSecondary outcomes
1
Salivary Biomarkers
The relationship between salivary biomarkers and burning mouth syndrome (BMS) symptoms.
Time frame
Baseline and follow up visit (12 weeks after baseline)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov