Evaluation of Voice in Behcet's

Voice and Behcet's Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Behcet Disease
• Intervention / Treatment: Other: 1-Laryngyscopic examination 2-Acoustic analysis

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).

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Wafaa Helmy Abd El-hakeem, MD; Phone Number: 01091813874; Email: dr.fofahma@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I; Group I will comprise of the 30 patients with Behçet's disease (BD).	Other: 1-Laryngyscopic examination 2-Acoustic analysis; 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).
Group II; Group II will comprise of 30 controls.	Other: 1-Laryngyscopic examination 2-Acoustic analysis; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency	frequency in hertz	baseline
laryngoscopic pictures	abnormal anatomical laryngeal findings like laryngeal congestion, bleeding, vocal fold polyps, cysts, nodules	baseline
jitter	jitter in percentage %	baseline
shimmer	shimmer in decibl	baseline
harmonic to noise ratio	harmonic to noise ratio in decibl	baseline

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2025
• Primary Completion (Estimated): May 15, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 15, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Vascular Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Eye Diseases; Skin Diseases; Skin Diseases, Vascular; Skin Diseases, Genetic; Uveal Diseases; Vasculitis; Panuveitis; Uveitis, Anterior; Uveitis; Hereditary Autoinflammatory Diseases; Behcet Syndrome
• Other Study ID Numbers: voice in Behcet's Disease

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No