Computational Modeling for Prediction of Acoustic Changes in Vowel Production Due to Orthognathic Surgery
PUMA
1 other identifier
interventional
20
1 country
1
Brief Summary
A computational model of human sound production based on high quality anatomic measurements and physical laws of sound propagation cannot be accomplished without a comprehensive data set including both 3D-images of the speaker's anatomy and the simultaneous recording of speech. Since the computational model has separate models for the vocal folds and the vocal tract, patients undergoing an orthognathic surgery is an optimal test object for the model development. Vocal folds remain unchanged while substantial changes take place in the vocal tract. Moreover, since the aim of the research is to predict acoustic changes in speech due to operations in head neck area, the orthognathic patient group is par excellence an example of such a prediction problem. If the model can be shown to give valuable information pre-operationally, many other patient groups could benefit from the results.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 28, 2013
CompletedFirst Posted
Study publicly available on registry
June 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 27, 2013
June 1, 2013
1.8 years
March 28, 2013
June 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acoustic changes in vowel production of hte patients duoe to orthognathic surgery
a measurement of sound formants
6 and 30 weeks postoperatively
Secondary Outcomes (1)
Anatomical changes in vocal tract due to orthognathic surgery
6 and 30 weeks postoperatively
Study Arms (1)
Computational modeling
EXPERIMENTALInterventions
The vocal and nasal tracts from the lips and nostrils to the beginning of the trachea are imaged with Siemens Avanto 1.5T MRI machine using carefully optimized, externally triggered imaging sequences that are synchronized with the rest of the experimental setting. A sound sample, given by the test subject, is recorded simultaneously to obtain a coupled data set: the speech sound and the precise anatomy which produces it.
Eligibility Criteria
You may qualify if:
- \- Healthy patients undergoing orthognathic surgery
You may not qualify if:
- Patients with conditions in which MRI examination is contraindicated (e.g. pace maker)
- Patients who require several operations or segmented jaw surgery
- Patients with cognitive impairment
- Patients with numerous dental amalgam fillings that may cause artifacts in MR images
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Turku University Hospital
Turku, F!-20521 Turku, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Risto P Happonen, Professor
Turku University Hospital, Po. Box 52, FI-20521 Turku, Finland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2013
First Posted
June 27, 2013
Study Start
March 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2014
Last Updated
June 27, 2013
Record last verified: 2013-06