Evaluation of Voice in Behcet's

Официальное название

Voice and Behcet's Disease

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое 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).

Первичные конечные точки

• laryngoscopic pictures [Срок оценки: baseline]
• frequency [Срок оценки: baseline]
• jitter [Срок оценки: baseline]
• shimmer [Срок оценки: baseline]
• harmonic to noise ratio [Срок оценки: baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• other autoimmune diseases.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06836817 · voice in Behcet's Disease

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗