ClinicalTrials.gov record NCT06836817

Evaluation of Voice in Behcet's

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 16, 2026

Voice and Behcet's Disease

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age10 years old and older
SexAll
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This retrospective observational case-control study compares people with Behçet's disease to control volunteers. It collects voice recordings, laryngoscopic images, and computerized acoustic measures. Researchers will look for vocal cord or laryngeal findings and whether these relate to demographic, clinical, or treatment features.

What it is studying. If vocal cord or laryngeal abnormalities occur in people with Behçet's disease, and whether those findings correlate with demographic, clinical, or treatment characteristics.

What the researchers hope to learn. To verify the occurrence of vocal cord involvement in Behçet's disease and to identify correlations with demographic, clinical, and therapeutic characteristics; to collect laryngoscopic images and acoustic voice measures.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Behçet's disease (BD) is a systemic inflammatory condition of unknown origin with no definite aetiopathogenetic pathways accepted worldwide. To date, only a few studies have investigated laryngeal involvement in BD and data about this are scarce. For these reasons, the present study focuses on verifying the occurrence of vocal cord involvement in patients with BD, identifying potential correlations with specific demographic, clinical, and therapeutic characteristics.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • 1-Laryngyscopic examination 2-Acoustic analysis

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • The inclusion criteria for selection of Group I participants will based on the criteria of the International Study Group which was proposed in 1990. The inclusion criteria for Group II will not have a Behcet's Disease.

Exclusion criteria

  • other autoimmune diseases.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Behçet's disease (BD) is a systemic inflammatory condition of unknown origin with no definite aetiopathogenetic pathways accepted worldwide. BD owes its name to the Turkish dermatologist Hulusi Behçet, whom published in 1937 two cases of oral aphthous, genital ulcers, and recurrent uveitis with hypopion, known as triple-symptom complex. In addition to these, other clinical features encompass musculoskeletal, gastrointestinal, renal, pulmonary, cardiovascular, and cutaneous manifestations including erythema nodosum and pseudofolliculitis.To date, only a few studies have investigated laryngeal involvement in BD and data about this are scarce. For these reasons, the present study focuses on verifying the occurrence of vocal cord involvement in patients with BD, identifying potential correlations with specific demographic, clinical, and therapeutic characteristics.The study will include 60 volunteers. They will divided into 2 groups. Group I will comprise of the 30 patients with Behçet's disease (BD), and Group II will comprise of 30 controls.The inclusion criteria for selection of Group I participants will based on the criteria of the International Study Group which was proposed in 1990. The inclusion criteria for Group II will not have a Behcet's Disease.Methods

  • History taking.
  • voice sample by recording (in sustained vowel \|a\| )
  • Auditory Perceptual Assessment (APA): (Kotby et al., 1986)
  • Laryngyscopic examination:

Patients will taken to a room with a tower on which the 8.5 mm 70 rigid laryngoscope (KARL STORZ - endoscope) (Tele pack X LED).

  • Acoustic analysis: The voice sample will be subjected to computerized acoustic analysis using Multidimensional voice program software(MDVP).
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will be assigned to one of two groups (about 30 people with Behçet's disease and 30 control volunteers). They will have a medical history taken and provide a voice recording of a sustained “a” sound. A clinician will perform an auditory perceptual assessment (APA) and a laryngoscopic examination using a rigid laryngoscope (the record specifies an 8.5 mm 70° rigid laryngoscope), and the voice recordings will undergo computerized acoustic analysis with the Multidimensional Voice Program (MDVP). The laryngoscopic exam may be uncomfortable for some people.

How the study is structured. Retrospective case-control observational study with two groups: about 30 people with Behçet's disease and 30 controls. Data collection and assessments include medical history, a sustained-vowel (/a/) voice recording, auditory perceptual assessment, rigid laryngoscopic examination, and computerized acoustic analysis (Multidimensional Voice Program). Primary measures recorded at baseline include laryngoscopic images and acoustic metrics such as frequency, jitter, shimmer, and harmonic-to-noise ratio.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • No sites are listed on the registry yet. Where will the study take place?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Behçet's disease

This trial is also listed on this site under familial Mediterranean fever.

Clinical trials34 trials listed for Behçet's diseaseEvery trial the registry lists for Behçet's disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Behçet's disease researchLatest monthly update: September 2026. Includes: Low-dose IL-2 trial. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Feb 15, 2025 (estimated)
Primary completion
May 15, 2025 (estimated)
Study completion
June 2025 (estimated)
Target enrollment
60 participants (estimated)
Last updated on registry
Feb 20, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Minia University
Principal investigator
Wafaa Helmy Abdelhakeem, doctor
Minia University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

inclusion criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Study Group
One of the groups in a study. Each arm receives a particular intervention, comparator or no intervention, so the groups can be compared.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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