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Completed

NCT Number: NCT02923908

Recording Facial Expressions to Assess Taste in Children and Teenagers

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.

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Key information

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Noldus Facereader 7

Other

A video recording of a subject's facial expressions while tasting a sweet, bitter, and neutral flavored liquid will be analyzed using Noldus Facereader 7 software.

Voice Recording

Other

A voice recording will be made for the duration of the tasting period.

5-Point Facial Hedonic Scale

Other

A 5-point facial hedonic scale will be given to the participant to complete prior to the administration of any test substances and about 5, 10, and 30 minutes after the administration of each test substance.

Follow-up Questionnaire

Other

Participants will be asked a few questions about each test agent after tastings.

Primary outcomes

  1. Evidence that recording of facial expressions can reliably distinguish between liquids that taste bitter, sweet, or have no taste

    Time frame: within one year of study procedure

    The investigators propose that Noldus Facereader 7 can adequately discriminate between bitter, sweet, and neutral tastes in children and adolescents. Data collected through these recordings will be compared to ratings of liking/disliking of liquids using a 5-point facial hedonic scale and compared to a questionnaire after each tasting.

Other outcomes

  1. Audio Recording During Study Procedure

    Time frame: within one year of study procedure

    An audio recording will occur during the tasting of each liquid in order to capture the subject's response to the liquid. This recording will be analyzed to determine a subject's liking/disliking of each test agent.

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Registry information

Official study title

A Pilot Study of Facial Recognition Software to Assess Palatability in Pediatric Patients

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 5, 2016
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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