Facial ExpressionNCT02923908
Recording Facial Expressions to Assess Taste in Children and Teenagers
An observational study of Facial Expression, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Expression
- What is being tested?
- Noldus Facereader 7, Voice Recording and 5-Point Facial Hedonic Scale
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 1 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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).
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
Official title: 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.
Read the 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.
- Conditions
- Facial Expression
- Being tested
- Noldus Facereader 7, Voice Recording, 5-Point Facial Hedonic Scale, Follow-Up Questionnaire
- Keywords
- Palatability, Pediatrics, Facial Recognition, Taste, Facial Expressions
- Medical subject headings
- Facial Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noldus Facereader 7Other
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 RecordingOther
A voice recording will be made for the duration of the tasting period.
5-Point Facial Hedonic ScaleOther
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 QuestionnaireOther
Participants will be asked a few questions about each test agent after tastings.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence that recording of facial expressions can reliably distinguish between liquids that taste bitter, sweet, or have no taste
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.
Measured: within one year of study procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startDec 2016
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Facial ExpressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory L Kearns, PharmD, PhD, Principal investigator, Arkansas Children's Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923908
- Sponsor's protocol ID
- GK003
- Other IDs
- 20162192
- Status last verified
- Apr 2018
- First submitted
- 30 Sep 2016
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be made available. However, the overall results of the study will be made available.
Publications
Walsh J, Cram A, Woertz K, Breitkreutz J, Winzenburg G, Turner R, Tuleu C; European Formulation Initiative. Playing hide and seek with poorly tasting paediatric medicines: do not forget the excipients. Adv Drug Deliv Rev. 2014 Jun;73:14-33. doi: 10.1016/j.addr.2014.02.012. Epub 2014 Mar 12.
PubMed 24614069Matsui D. Current issues in pediatric medication adherence. Paediatr Drugs. 2007;9(5):283-8. doi: 10.2165/00148581-200709050-00001.
PubMed 17927300Wollner A, Lecuyer A, De La Rocque F, Sedletzki G, Derkx V, Boucherat M, Elbez A, Gelbert-Baudino N, Levy C, Corrard F, Cohen R. [Acceptability, compliance and schedule of administration of oral antibiotics in outpatient children]. Arch Pediatr. 2011 May;18(5):611-6. doi: 10.1016/j.arcped.2011.02.010. Epub 2011 Mar 21. French.
PubMed 21420838Winnick S, Lucas DO, Hartman AL, Toll D. How do you improve compliance? Pediatrics. 2005 Jun;115(6):e718-24. doi: 10.1542/peds.2004-1133.
PubMed 15930200Sjovall J, Fogh A, Huitfeldt B, Karlsson G, Nylen O. Methods for evaluating the taste of paediatric formulations in children: a comparison between the facial hedonic method and the patients' own spontaneous verbal judgement. Eur J Pediatr. 1984 Feb;141(4):243-7. doi: 10.1007/BF00572770.
PubMed 6734676Tolia V, Johnston G, Stolle J, Lee C. Flavor and taste of lansoprazole strawberry-flavored delayed-release oral suspension preferred over ranitidine peppermint-flavored oral syrup: in children aged between 5-11 years. Paediatr Drugs. 2004;6(2):127-31. doi: 10.2165/00148581-200406020-00006.
PubMed 15035653Mennella JA, Spector AC, Reed DR, Coldwell SE. The bad taste of medicines: overview of basic research on bitter taste. Clin Ther. 2013 Aug;35(8):1225-46. doi: 10.1016/j.clinthera.2013.06.007. Epub 2013 Jul 22.
PubMed 23886820Mennella 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.
PubMed 25050705Danner, 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.
Loijens, Leanne, et. al. FaceReader: Reference Manual Version 7. Noldus Information Technology. Wageningen, 2016, pp. 55.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Facial Recognition Software to Assess Palatability in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02923908
- Acronym / sponsor ID
- GK003
- Conditions
- Facial Expression
- Keywords
- Palatability, Pediatrics, Facial Recognition, Taste, Facial Expressions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noldus Facereader 7A 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. | Other | – |
| Voice RecordingA voice recording will be made for the duration of the tasting period. | Other | – |
| 5-Point Facial Hedonic ScaleA 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. | Other | – |
| Follow-Up QuestionnaireParticipants will be asked a few questions about each test agent after tastings. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Background: PubMed 24614069Walsh J, Cram A, Woertz K, Breitkreutz J, Winzenburg G, Turner R, Tuleu C; European Formulation Initiative. Playing hide and seek with poorly tasting paediatric medicines: do not forget the excipients. Adv Drug Deliv Rev. 2014 Jun;73:14-33. doi: 10.1016/j.addr.2014.02.012. Epub 2014 Mar 12.
- Background: PubMed 17927300Matsui D. Current issues in pediatric medication adherence. Paediatr Drugs. 2007;9(5):283-8. doi: 10.2165/00148581-200709050-00001.
- Background: PubMed 21420838Wollner A, Lecuyer A, De La Rocque F, Sedletzki G, Derkx V, Boucherat M, Elbez A, Gelbert-Baudino N, Levy C, Corrard F, Cohen R. [Acceptability, compliance and schedule of administration of oral antibiotics in outpatient children]. Arch Pediatr. 2011 May;18(5):611-6. doi: 10.1016/j.arcped.2011.02.010. Epub 2011 Mar 21. French.
- Background: PubMed 15930200Winnick S, Lucas DO, Hartman AL, Toll D. How do you improve compliance? Pediatrics. 2005 Jun;115(6):e718-24. doi: 10.1542/peds.2004-1133.
- Background: PubMed 6734676Sjovall J, Fogh A, Huitfeldt B, Karlsson G, Nylen O. Methods for evaluating the taste of paediatric formulations in children: a comparison between the facial hedonic method and the patients' own spontaneous verbal judgement. Eur J Pediatr. 1984 Feb;141(4):243-7. doi: 10.1007/BF00572770.
- Background: PubMed 15035653Tolia V, Johnston G, Stolle J, Lee C. Flavor and taste of lansoprazole strawberry-flavored delayed-release oral suspension preferred over ranitidine peppermint-flavored oral syrup: in children aged between 5-11 years. Paediatr Drugs. 2004;6(2):127-31. doi: 10.2165/00148581-200406020-00006.
- Background: PubMed 23886820Mennella JA, Spector AC, Reed DR, Coldwell SE. The bad taste of medicines: overview of basic research on bitter taste. Clin Ther. 2013 Aug;35(8):1225-46. doi: 10.1016/j.clinthera.2013.06.007. Epub 2013 Jul 22.
- Background: PubMed 25050705Mennella 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.
- BackgroundDanner, 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.
- BackgroundLoijens, Leanne, et. al. FaceReader: Reference Manual Version 7. Noldus Information Technology. Wageningen, 2016, pp. 55.
- Noldus WebsiteLink provided by the sponsor.
- Noldus website "What's New in Facereader 7?"Link provided by the sponsor.
- FDA Approval of Prednisone Oral Solution 5mg/5mLLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be made available. However, the overall results of the study will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory L Kearns, PharmD, PhD principal investigator
Arkansas Children's Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Expression, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02923908, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.