- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02923908
Recording Facial Expressions to Assess Taste in Children and Teenagers
A Pilot Study of Facial Recognition Software to Assess Palatability in Pediatric Patients
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72202
- Arkansas Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
within one year of study procedure
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
within one year of study procedure
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gregory L Kearns, PharmD, PhD, Arkansas Children's Research Institute
Publications and helpful links
General 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.
- Matsui D. Current issues in pediatric medication adherence. Paediatr Drugs. 2007;9(5):283-8. doi: 10.2165/00148581-200709050-00001.
- Wollner 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.
- Winnick 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.
- Sjovall 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.
- Tolia 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.
- Mennella 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.
- 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.
- 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.
- Loijens, Leanne, et. al. FaceReader: Reference Manual Version 7. Noldus Information Technology. Wageningen, 2016, pp. 55.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GK003
- 20162192 (Other Identifier: Western Institutional Review Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Facial Expression
-
University of Nove de JulhoRecruitingWrinkle | Facial ExpressionBrazil
-
Mohamed Hayder Oleish SalihCompletedGlabellar Frown Lines | Wrinkle | Facial Expression | RhytidesEgypt
-
University of OxfordMedical Research Council; P1vital Products LimitedCompletedEmotion | Bright Light Treatment | Facial Expression RecognitionUnited Kingdom
-
Universidade Metropolitana de SantosCompletedFacial Expression | Bichat's Fat Pad AtrophyBrazil
-
Seoul National University Bundang HospitalRecruitingPain, Postoperative | Analgesia | Artificial Intelligence | Facial ExpressionKorea, Republic of
-
Galderma R&DCompletedGene ExpressionUnited States
-
Moy-Fincher-Chipps Facial Plastics and DermatologyUnknown
-
University of California, Los AngelesCompleted
-
Laval UniversityCompleted
-
Winthrop UniversityRecruiting
Clinical Trials on Noldus Facereader 7
-
Oklahoma State University Center for Health SciencesOral Roberts UniversityRecruiting
-
Pamela PetersenCompleted
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); Cancer Immunotherapy Trials Network (CITN)TerminatedHIV Infection | Kaposi Sarcoma | AIDS-Related Kaposi SarcomaUnited States
-
Cytheris, Inc.CompletedAML | MDS | CMLUnited States
-
Cytheris SACompletedHIV Infections | LymphopeniaUnited States, France, Canada, Italy
-
Masonic Cancer Center, University of MinnesotaPfizerCompletedCervical Cancer | Breast Cancer | Ovarian Cancer | Endometrial CancerUnited States
-
University of North Carolina, Chapel HillJohns Hopkins University; Novartis PharmaceuticalsCompletedCystic FibrosisUnited States
-
University of North Carolina, Chapel HillCystic Fibrosis FoundationRecruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAcute Myeloid Leukemia | Myelodysplastic Syndrome | Myeloproliferative Neoplasm | Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Cord Blood Transplant RecipientUnited States
-
Hyunseok Kang, MDNeoImmuneTechRecruitingRecurrent Head and Neck Squamous Cell Carcinoma | Recurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Resectable Oropharyngeal Squamous Cell CarcinomaUnited States