NCT05876247

Brief 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.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

November 10, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

May 16, 2023

Last Update Submit

May 25, 2023

Conditions

Keywords

Articulation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Individuals treated for oral cancer

Dutch native speakers (18+) who will undergo surgical treatment for a T1 or T2 tumour on the tongue.

Other: Electromagnetic Articulography

Control speakers

Dutch native speakers (18+) without self-reported speech problems.

Other: Electromagnetic Articulography

Interventions

Motion tracking sensors will track articulatory movements of the tongue, jaw and lips

Control speakersIndividuals treated for oral cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with and without oral cancer who speak Dutch as their native language

You may qualify if:

  • Diagnosed with T1 or T2 tumor in the oral cavity
  • At least 18 years old and able to provide informed consent
  • Native speaker of Dutch
  • Has nog been treated for oral cancer before

You may not qualify if:

  • a. Recurrence of disease (for patients)
  • b. 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.
  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Arts, University of Groningen

Groningen, 9712 EK, Netherlands

RECRUITING

University Medical Centre Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckSpeech Disorders

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Max Witjes, PhD

    University of Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 25, 2023

Study Start

November 10, 2022

Primary Completion

August 1, 2024

Study Completion

August 1, 2025

Last Updated

May 30, 2023

Record last verified: 2023-05

Locations