Clinical trial NCT02923908: Recording Facial Expressions to Assess Taste in Children and Teenagers
Official title: A Pilot Study of Facial Recognition Software to Assess Palatability in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Facial Expression
Keywords: Palatability
Pediatrics
Facial Recognition
Taste
Facial Expressions
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 12
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be recruited via IRB approved advertisements and from the ACRI database for which subjects have given prior permission to be contacted for research studies. A convenience sample will be comprised of 10 children and/or adolescents ranging in age from 7 to 16 years of age. A total of 13 subjects may be enrolled in the event that a subject is unable to meet criteria and/or needs to withdraw. If the study attains 10 evaluable subjects, then additional participants will not be enrolled.

Brief summary: The study is designed to see if, after tasting specific things, whether a child's facial pattern and voice pattern can determine the difference in something that has a sweet taste, no taste, and a bitter taste. The investigators will do this by comparing video recordings of a child's facial expression and voice to the child's response to follow-up questions after tasting three (3) different substances.

Detailed description: Participants will taste three different substances in random order: 1. Prednisone liquid (a commonly used medicine to treat swelling which is approved by the Food and Drug Administration) for use in children; 2. A solution of table sugar in water (simple syrup); and 3. Ora-Plus, which is a solution that can be added to medicines. Ora-Plus is considered safe for use in children's formulas and all of the ingredients of Ora-Plus are on the Food and Drug Administration (FDA) Generally Regarded as Safe (GRAS) list. About 1 ml of each substance will be placed directly onto the tongue. Each substance will be tasted for 5-10 seconds and then, expectorated. Participants and investigators recording responses will be blinded with regard to the identity of test substances.

Facial expression will be recorded prior to administration of the taste substances and for approximately 2 minutes thereafter. An audio recording of the participant's voice will also be made during this time. At about 5 and 10 minutes after a given taste substance is administered, participants will be asked to identify a face on a 5-point facial hedonic scale which shows the participant's taste perception. Participants will also be asked to describe the taste sensation experienced as sweet, bitter or neutral (no apparent taste).

Participants will have a 30-minute rest period after administration of each taste substance which will include the administration of water and a neutral food to enable cleansing of the palate. The procedure above will be repeated in the same way for each of the 3 test substances.

Eligibility criteria: Inclusion Criteria:

Participants will be eligible if all of the following criteria is met:

* Verbal assent and parental consent provided.
* Males and females between 7 and ≤16 years of age (n= 3-5 in group 7 to 11 years and n= 4-5 in group 12 to ≤16 years. An additional 3 participants may be recruited if a recording does not produce viable data.)
* Both parent and participant speak English proficiently

Exclusion Criteria:

Participants will not be eligible if any of the following criteria is met:

* Unwillingness to participate.
* Participants of Asian ethnicity (N.B. The current FaceReader software cannot correctly identify facial expressions in these children and as a result cannot produce an analysis suitable to this study.14)
* Any medical condition or recent event that would cause a study participant to be unable to taste or swallow study agents.
* Any medical condition, previous surgery, or recent event affecting the tongue or palate that would cause taste alteration or aversion (i.e. ulcerations or infection of the tongue, soft or hard palate).
* Any medical condition or recent event that would preclude a study participant from having an intact sense of smell (i.e. anosmia, history of severe sinus infections, recent upper respiratory infection with congestion).
* Had a dentist visit within 14 days prior to enrollment or the time between enrollment and receipt of study articles.
* Any history of allergy, hypersensitivity, or intolerance to prednisone, sugar, food dyes, or any of the constituents of Ora-Plus.
* Any prior history of cardiac or gastrointestinal problems with the exception of self-limited conditions common to pediatric patients.
* Have ingested any medication or food substance 60 minutes prior to administration of the test articles.
* If the participant is the child or a first-degree relative to any of the investigators.
* Any profound sensory deficit (i.e. vision or hearing) that may interfere with the ability to comply with study related demands.
* Neurocognitive Disorders that could limit interpretation of results and their generalizability.
* History of a chronic illness.
* Use of mouthwash within 24 hours of study visit.
* Participant does not pass the baseline medical assessment.

Primary outcomes:
measure: Evidence that recording of facial expressions can reliably distinguish between liquids that taste bitter, sweet, or have no taste
timeFrame: within one year of study procedure
Secondary outcomes:
Other outcomes:
measure: Audio Recording During Study Procedure
timeFrame: within one year of study procedure
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: Arkansas Children's Research Institute
name: Gregory L Kearns, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Mennella JA, Reed DR, Roberts KM, Mathew PS, Mansfield CJ. Age-related differences in bitter taste and efficacy of bitter blockers. PLoS One. 2014 Jul 22;9(7):e103107. doi: 10.1371/journal.pone.0103107. eCollection 2014.
citation: Danner, Lukas, Liudmila Sidorkina, Max Joechl, Klaus Duerrschmid. Make a face! Implicit and explicit measurement of facial expressions elicited by orange juices using face reading technology. Elsevier: Food Quality and Preference. 2013; 32:167-172.
citation: Loijens, Leanne, et. al. FaceReader: Reference Manual Version 7. Noldus Information Technology. Wageningen, 2016, pp. 55.