Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06836817

Evaluation of Voice in Behcet's

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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

  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1-Laryngyscopic examination 2-Acoustic analysis

Other
  • 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).

Primary outcomes

  1. laryngoscopic pictures

    Time frame: baseline

    abnormal anatomical laryngeal findings like laryngeal congestion, bleeding, vocal fold polyps, cysts, nodules

  2. frequency

    Time frame: baseline

    frequency in hertz

  3. jitter

    Time frame: baseline

    jitter in percentage %

  4. shimmer

    Time frame: baseline

    shimmer in decibl

  5. harmonic to noise ratio

    Time frame: baseline

    harmonic to noise ratio in decibl

Study contacts

Contact information is provided by the study sponsor or research team.

Wafaa Helmy Abd El-hakeem, MD

CONTACT

[email protected]

01091813874

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Voice and Behcet's Disease

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.