Clinical trial NCT05819697: Reducing Patient Memory Recall in the Burning Mouth Patient Population
Official title: FIRE Trial: Reducing Patient Memory Recall in the Burning Mouth Patient Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Burning Mouth Syndrome
Keywords: burning mouth syndrome
oral pain
burning mouth
chronic intraoral burning sensation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population will be patients who have been diagnosed with burning mouth syndrome by Oral Medicine specialists.

Brief summary: 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.

Detailed description: This is a prospective study with the aims: (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.

Participants will attend 2 study visits. Visit 1 of the study will consist of screening during the baseline visit. It will include administration of questionnaires, informed consent, collection of salivary samples, helping to download the app and/or helping to set up the smartphone to receive text notifications, and assisting with the demonstration of taking surveys on smartphones.

Track Your Happiness app, a smartphone and/or text-based notification system to take surveys, will collect data on people's experiences across a random sample of the moments of their lives. Participants will receives notifications 3 times per day at random times, and will be prompted to answer questions related to the burning mouth, to exercise, and a random selection of non-clinical Track Your Happiness questions, e.g., "Are you interacting with anyone right now?" "How do you feel right now?" Participants will receive these notifications for 12 weeks.

The final study visit (visit 2) will take place 12 weeks after Visit 1. Visit 2 will consist of questionnaires and collection of salivary samples.

Eligibility 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

Primary outcomes:
measure: Track Your Happiness App utilization for Burning Mouth Syndrome (BMS) symptom reports in real time
timeFrame: 12 weeks
Secondary outcomes:
measure: Salivary Biomarkers
timeFrame: Baseline and follow up visit (12 weeks after baseline)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Penn Dental School of Medicine, Center for Clinical and Translational Research
name: Eugene Ko, DDS
role: PRINCIPAL_INVESTIGATOR
References: