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Not yet recruiting NCT06836817

Evaluation of Voice in Behcet's

— Observational Behcet Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 1-Laryngyscopic examination 2-Acoustic analysis.
Who it may be relevant to
Registry conditions: Behcet Disease. Basic parameters: from 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Voice and Behcet's Disease

Overview

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.

Detailed description

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

1. History taking. 2. voice sample by recording (in sustained vowel \|a\| ) 3. Auditory Perceptual Assessment (APA): (Kotby et al., 1986) 4. 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). 5. Acoustic analysis: The voice sample will be subjected to computerized acoustic analysis using Multidimensional voice program software(MDVP).

Interventions

  • Other 1-Laryngyscopic examination 2-Acoustic analysis
    1. History taking. 2. voice sample by recording (in sustained vowel \|a\| ) 3. Auditory Perceptual Assessment (APA): (Kotby et al., 1986) 4. 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). 5. Acoustic analysis: The voice sample will be subjected to computerized acoustic analysis using Multidimensional voice program software(MDVP).

Primary outcome measures

  • laryngoscopic pictures [Time frame: baseline]
  • frequency [Time frame: baseline]
  • jitter [Time frame: baseline]
  • shimmer [Time frame: baseline]
  • harmonic to noise ratio [Time frame: baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06836817 · voice in Behcet's Disease

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗