Reducing Patient Memory Recall in the Burning Mouth Patient Population

Burning Mouth Syndrome Clinical Trial

Official title:

FIRE Trial: Reducing Patient Memory Recall in the Burning Mouth Patient Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05819697
• Other study ID #: 843642
• Status: Recruiting
• Start date: March 14, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: Eugene Ko, DDS
• Phone: 215-573-8177
• Email: PDMTranslationalMed[@]dental.upenn.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burning Mouth Syndrome
• Burns

Intervention

Other:
• FIRE Trial/Track Your Happiness notifications
All 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?"

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	Salivary Biomarkers	The relationship between salivary biomarkers and burning mouth syndrome (BMS) symptoms.	Baseline and follow up visit (12 weeks after baseline)