NCT06836817

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

Completed
9 days until next milestone

Study Start

First participant enrolled

February 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

February 6, 2025

Last Update Submit

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).

Other: 1-Laryngyscopic examination 2-Acoustic analysis

Group II

Group II will comprise of 30 controls.

Other: 1-Laryngyscopic examination 2-Acoustic analysis

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).

Group IGroup II

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may not qualify if:

  • other autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Behcet Syndrome

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Vascular

Central Study Contacts

Wafaa Helmy Abd El-hakeem, MD

CONTACT

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