Computational Modeling for Prediction of Acoustic Changes in Vowel Production Due to Orthognathic Surgery (PUMA)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2013 by Turku University Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Turku University Hospital

ClinicalTrials.gov Identifier:

NCT01887977

First received: March 28, 2013

Last updated: June 24, 2013

Last verified: June 2013

History of Changes

Purpose

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.

Condition	Intervention
Jaw Deformity Facial Asymmetry	Other: MRI examination


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Computational Modeling for Prediction of Acoustic Changes in Vowel Production

Resource links provided by NLM:

Genetics Home Reference related topics: Crouzon syndrome branchio-oculo-facial syndrome

U.S. FDA Resources

Further study details as provided by Turku University Hospital:

Primary Outcome Measures:

Acoustic changes in vowel production of hte patients duoe to orthognathic surgery [ Time Frame: 6 and 30 weeks postoperatively ] [ Designated as safety issue: No ]
a measurement of sound formants

Secondary Outcome Measures:

Anatomical changes in vocal tract due to orthognathic surgery [ Time Frame: 6 and 30 weeks postoperatively ] [ Designated as safety issue: No ]
changes in vocal track dimensions


Estimated Enrollment:	20
Study Start Date:	March 2012
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Computational modeling	Other: MRI examination 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 Name: with Siemens Avanto 1.5T MRI machine

Arms

Assigned Interventions

Experimental: Computational modeling

Other: MRI examination

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 Name: with Siemens Avanto 1.5T MRI machine

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.

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01887977

Locations


Finland
Turku University Hospital	Recruiting
Turku, Finland, F!-20521 Turku
Contact: Risto P Happonen, Professor +358-50-4121477 risto-pekka.happonen@tyks.fi

Sponsors and Collaborators

Turku University Hospital

Investigators


Principal Investigator:	Risto P Happonen, Professor	Turku University Hospital, Po. Box 52, FI-20521 Turku, Finland

More Information


Responsible Party:	Turku University Hospital
ClinicalTrials.gov Identifier:	NCT01887977 History of Changes
Other Study ID Numbers:	T17/2012
Study First Received:	March 28, 2013
Last Updated:	June 24, 2013
Health Authority:	Finland: Ethics Committee

Keywords provided by Turku University Hospital:


Orthognathic surgery Speech production MRI

Additional relevant MeSH terms:


Jaw Abnormalities Jaw Diseases Congenital Abnormalities Facial Asymmetry Pathological Conditions, Anatomical Musculoskeletal Diseases	Maxillofacial Abnormalities Craniofacial Abnormalities Musculoskeletal Abnormalities Stomatognathic Diseases Stomatognathic System Abnormalities

ClinicalTrials.gov processed this record on September 27, 2016

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