Evaluation of Voice in Behcet's
Voice and Behcet's Disease
1 other identifier
observational
60
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2025
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2025
CompletedStudy Start
First participant enrolled
February 15, 2025
CompletedFirst Posted
Study publicly available on registry
February 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedFebruary 20, 2025
February 1, 2025
3 months
February 6, 2025
February 15, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
laryngoscopic pictures
abnormal anatomical laryngeal findings like laryngeal congestion, bleeding, vocal fold polyps, cysts, nodules
baseline
frequency
frequency in hertz
baseline
jitter
jitter in percentage %
baseline
shimmer
shimmer in decibl
baseline
harmonic to noise ratio
harmonic to noise ratio in decibl
baseline
Study Arms (2)
Group I
Group I will comprise of the 30 patients with Behçet's disease (BD).
Group II
Group II will comprise of 30 controls.
Interventions
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).
Eligibility Criteria
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.
You may not qualify if:
- other autoimmune diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
February 6, 2025
First Posted
February 20, 2025
Study Start
February 15, 2025
Primary Completion
May 15, 2025
Study Completion
June 1, 2025
Last Updated
February 20, 2025
Record last verified: 2025-02