Levator Veli Palatini Constriction and Voice Function in Children with Cleft Palate

Study on Muscle Contraction and Voice Function in Children with Cleft Palate

R
Robert Fujiki

Primary Investigator

Enrolling By Invitation
4 years - 17 years
All
Phase N/A
20 participants needed
1 Location

Brief description of study

The focus of this study will be determining if levator veli palatini muscle contraction is associated with vocal fold function in children with cleft palate. We seek to determine the relationship between voice and palate function in this population.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Childen between the ages of 4-18 years of age will be recruited for participation in this study through Riley Hospital for Children. including both those with cleft palate and healthy controls.  A member of the study personnel will speak with potential participants to gauge interest in the study and prescreen for eligibility. Eligibility will be confirmed by the Investigators, and if the participant meets all criteria, the research visit will be scheduled.

Detailed description of study

The research study will require up to 2 visits (can be done in 1), and will take up to 60 to 75 minutes. The MRI methods used in the present study are modeled after previously published studies. Pertinent details (date of birth, exact age at scan, sex, race, all medical diagnoses, surgical history, palatoplasty operative note, most recent cleft team report, most recent hearing evaluation, weight, height, head circumference) from the medical chart will be pulled following study participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Healthy, Cleft palate
  • Age: 4 years - 17 years
  • Gender: All

Inclusion Criteria: 
-    Cleft Palate Group:
o    Age 4 to 17 years
o    Medical diagnosis of cleft palate (either cleft palate only or cleft lip with cleft palate)
o    Willingness to participate following informed consent discussion

-    Healthy Control Group:
o    Healthy children/adolescents age 4 to 17 years
o    Willingness to participate following informed consent discussion

This study investigates the relationship between the contraction of the levator veli palatini muscle and vocal fold function in children with cleft palate. Cleft palate is a condition where there is an opening in the roof of the mouth, which can affect speech and other functions. The study aims to understand how the muscle involved in lifting the soft palate affects the voice in affected children.

The study procedures include MRI scans to observe muscle and voice function. MRI, or Magnetic Resonance Imaging, is a way to take pictures of the inside of the body. The study will collect various details from participants' medical charts, such as age, medical history, and recent evaluations, to help understand the findings.

  • Who can participate: Children aged 4 to 17 years with a medical diagnosis of cleft palate or healthy children in the same age range can participate. Participants must be willing to join the study after a discussion about informed consent.
  • Study details: This is an observational study. Participants will undergo MRI scans, which are used to take detailed images of the body. The study will collect information from medical charts, including medical history and recent evaluations, to support the analysis.
  • Study timelines and visits: The study will last 60 to 75 minutes. The study requires 2 visits.
Updated on 26 Jan 2026. Study ID: OTHN-IIR-CLEFT-CHILDREN, 29340
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only