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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05876247
Other study ID # METc 2021/711
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 10, 2022
Est. completion date August 2025

Study information

Verified date May 2023
Source University Medical Center Groningen
Contact Thomas Tienkamp, MA
Phone +31 50 36 37051
Email t.b.tienkamp@umcg.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this longitudinal study is to learn more about the articulatory consequences of surgical oral cancer treatment. The main aims are to study the coordination and development of speech articulation of patients who will undergo surgical treatment for oral cancer longitudinally and whether individual differences in the reliance on auditory or tactile information can predict the success of speech compensatory strategies. Participants will perform multiple speech tasks while motion tracking sensors track the articulatory gestures.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 2025
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Diagnosed with T1 or T2 tumor in the oral cavity 2. At least 18 years old and able to provide informed consent 3. Native speaker of Dutch 4. Has nog been treated for oral cancer before Exclusion Criteria: 1a. Recurrence of disease (for patients) 1b. Treated for oral cancer (for healthy controls) 2. Speech problems (e.g., stuttering) 3. Problems with sight or hearing that impede reading or understanding instructions. When glasses or a hearing aid resolve these problems, then participants are not excluded. 4. Neurological or psychological disorders (e.g., stroke) 5. Non-removable metal in, on or around the head (piercings, braces, pacemaker, electrodes) 6. Self-reported signs of depression

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Electromagnetic Articulography
Motion tracking sensors will track articulatory movements of the tongue, jaw and lips

Locations

Country Name City State
Netherlands Faculty of Arts, University of Groningen Groningen
Netherlands University Medical Centre Groningen Groningen

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Articulatory gestures Articulatory movements in three dimensions of the tongue, lips and jaw as measured by the NDI Vox Electromagnetic Articulograph. Measures include: articulator speed (mm/s), total displacement (mm), coordinates (x,y,z) during specific gestures. 2022-2025
Primary Acoustic outcomes Speech acoustics will be measured in Praat and include the first and second formants of vowels (in Hz), global movement size in terms of acoustic working space (Hz-squared), and the centre of gravity of sibilants (in Hz) 2022-2025
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