NCT06439290 Voice Outcome of Glottoplasty, Cricothyroid Approximation, Thyroplasty, and Chondrolaryngoplasty
| NCT ID | NCT06439290 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Ghent |
| Condition | Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 290 participants |
| Start Date | 2024-04-10 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 290 participants in total. It began in 2024-04-10 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to measure the short- and long-term voice outcome and outcome predictors of glottoplasty, cricothyroid approximation, thyroplasty, and chondrolaryngoplasty using a prospective non-randomized controlled trial and a multidimensional voice assessment protocol. Secondly, a laryngeal magnetic resonance imaging protocol will be developed to measure pre- and postoperative anatomical factors and compare them with the acoustic changes.
Eligibility Criteria
PURPOSE 1: Inclusion criteria for surgery participants: * Persons who will soon undergo surgery on the vocal folds and/or larynx (including glottoplasty, cricothyroid approximation, thyroplasty and/or thyroid chondroplasty) at UZ Gent * At least 18 years old * Sufficient command of the Dutch language for understanding the informed consent letter and completing Dutch questionnaires Inclusion criteria for volunteers to provide speech samples: \- Cisgender men or women Inclusion criteria for volunteer listeners for the listening experiment: * Dutch-speaking * Self-reported normal hearing PURPOSE 2: same as above. PURPOSE 3: Inclusion criteria for the healthy participants: * At least 18 years old * Sufficient command of the Dutch language to complete a Dutch questionnaire Exclusion criteria for the healthy participants: \- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist). Inclusion criteria for the pre- and postoperative MRI participants: \- Random selection of +- 10 participants of purpose 1. Exclusion criteria for the pre- and postoperative MRI participants: \- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).
Contact & Investigator
Clara Leyns, PhD
STUDY DIRECTOR
University Ghent
Frequently Asked Questions
Who can join the NCT06439290 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06439290 currently recruiting?
Yes, NCT06439290 is actively recruiting participants. Contact the research team at evelien.dhaeseleer@ugent.be for enrollment information.
Where is the NCT06439290 trial being conducted?
This trial is being conducted at Ghent, Belgium, Ghent, Belgium.
Who is sponsoring the NCT06439290 clinical trial?
NCT06439290 is sponsored by University Ghent. The principal investigator is Clara Leyns, PhD at University Ghent. The trial plans to enroll 290 participants.