NCT01887977

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 27, 2013

Status Verified

June 1, 2013

Enrollment Period

1.8 years

First QC Date

March 28, 2013

Last Update Submit

June 24, 2013

Conditions

Keywords

Orthognathic surgerySpeech productionMRI

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

EXPERIMENTAL
Other: MRI examination

Interventions

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.

Also known as: with Siemens Avanto 1.5T MRI machine
Computational modeling

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

RECRUITING

MeSH Terms

Conditions

Jaw AbnormalitiesFacial Asymmetry

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Risto P Happonen, Professor

    Turku University Hospital, Po. Box 52, FI-20521 Turku, Finland

    PRINCIPAL INVESTIGATOR

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

Locations