- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01887977
Computational Modeling for Prediction of Acoustic Changes in Vowel Production Due to Orthognathic Surgery (PUMA)
June 24, 2013 updated by: Turku University Hospital
Computational Modeling for Prediction of Acoustic Changes in Vowel Production
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Orthognathic surgery deals with the correction of abnormalities of the facial tissues.
The underlying cause for abnormality may be present at birth or acquired during the life as the result of distorted growth or trauma.
Orthodontic treatment alone is not adequate in many cases due to severity of the deformities.
In a typical operation, the position of either one jaw (mandible or maxilla) or both jaws is surgically changed in relation to the skull base.
The movement of the jaw position varies usually between 5-15 mm either to anterior or posterior direction.
Such a considerable movement has a very profound effect on the shape and volume of vocal tract resulting detectable changes in acoustics.
Although the surgery involves mandibular and maxillary bone, changes occur also in the position and shape of respective soft tissues and hyoid bone, as well.
For this project, 20 adult patients (10 women and 10 men) undergoing orthognathic surgery will be enrolled.
Exclusion criteria include diseases and conditions in which MRI examination is contraindicated (.e.g.
pace maker), severe speech or hearing impairment, and other situations where the patient has difficulties with completing the tasks defined in the research protocol.
Furthermore, patients to whom segmental surgery of the jaws will be performed in connection of orthognathic surgery are excluded.
A specific pre-selection criterion for patients is the presence of numerous dental amalgam fillings that may cause artifacts in MR images.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Turku, Finland, F!-20521 Turku
- Recruiting
- Turku University Hospital
-
Contact:
- Risto P Happonen, Professor
- Phone Number: +358-50-4121477
- Email: risto-pekka.happonen@tyks.fi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy patients undergoing orthognathic surgery
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Computational modeling
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acoustic changes in vowel production of hte patients duoe to orthognathic surgery
Time Frame: 6 and 30 weeks postoperatively
|
a measurement of sound formants
|
6 and 30 weeks postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anatomical changes in vocal tract due to orthognathic surgery
Time Frame: 6 and 30 weeks postoperatively
|
changes in vocal track dimensions
|
6 and 30 weeks postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Risto P Happonen, Professor, Turku University Hospital, Po. Box 52, FI-20521 Turku, Finland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
March 28, 2013
First Submitted That Met QC Criteria
June 24, 2013
First Posted (Estimate)
June 27, 2013
Study Record Updates
Last Update Posted (Estimate)
June 27, 2013
Last Update Submitted That Met QC Criteria
June 24, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- T17/2012
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.
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