Recording Facial Expressions to Assess Taste in Children and Teenagers
Status: | Completed |
---|---|
Conditions: | Other Indications |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 7 - 16 |
Updated: | 4/17/2018 |
Start Date: | December 2016 |
End Date: | June 1, 2017 |
A Pilot Study of Facial Recognition Software to Assess Palatability in Pediatric Patients
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.
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.
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.
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.
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.
We found this trial at
1
site
1 Children's Way
Little Rock, Arkansas 72202
Little Rock, Arkansas 72202
(501) 364-1100
Principal Investigator: Gregory L Kearns, PharmD, PhD
Phone: 501-364-7373
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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