Laryngeal Manifestations of Connective Tissue Diseases

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04582292
Collaborator
(none)
50
13

Study Details

Study Description

Brief Summary

Connective tissue diseases represent a rather heterogeneous spectrum of overlapping pathologies, which have as a common feature the involvement of multiple organ systems. Though generally uncommon, they represent lifelong conditions, which are often coupled with various immunologic disorders, thus significantly affecting the overall health and quality of life of the affected individual. The classic connective tissue disorders include rheumatoid arthritis ,Juvenile idiopathic arthritis, systemic lupus erythematosus , scleroderma, Sjogren's syndrome, and the mixed connective tissue disease several studies have reported that up to fifty percent of connective tissue diseases' patients are having laryngeal involvement as the sole manifestation of this disease In acute phases, patients may complain of burning, foreign body sensation in the throat, and difficulty in swallowing. In chronic cases the cricoarytenoid joint is usually affected with resultant fixation. The laryngoscopic findings include mucosal edema, myositis of the intrinsic laryngeal muscles, hyperemia, inflammation and swelling of the arytenoids, interarytenoid mucosa, aryepiglottic folds and epiglottis, and impaired mobility or fixation of the cricoarytenoid joint. In the early stage of the disease, the laryngeal examination may be normal

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In acute involvement of the cricoarytenoid joints, signs of inflammation such as edema and redness may be present with or without impaired mobility chronic cases where ankylosis of the connective tissue disease cricoarytenoid joint is present, one or both vocal folds may be fixed in the median, paramedian, or lateral positions. Other laryngoscopic findings include the presence of inflammatory masses or rheumatoid nodules in the larynx and pharynx. In 1987, the American Rheumatism Association has included submucosal nodules in the laryngeal tissue in her revised criteria for the classification of Rheumatoid arthritis there was a description of small submucous rheumatoid nodule in the larynx, were later confirmed by multiple studies . Rheumatoid deposits in the form of bamboo nodes which are white- yellow bands in the middle of the membranous portion of the vocal folds had been described Cricoarytenoiditis has been reported to occur in Juvenile rheumatoid arthritis, and sometimes, it may be the first presentation of the disease ,Vocal cord lesions that have been reported in connective tissue diseases diseases include cricoarytenoid arthritis, rheumatoid nodules, and bamboo nodes .

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Laryngeal Manifestations of Connective Tissue Diseases
    Anticipated Study Start Date :
    Nov 1, 2020
    Anticipated Primary Completion Date :
    Apr 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Subjective measurement of severity of dysphonia connective tissue disease. [Baseline]

      Measurement of grades of dysphonia,strain,leakiness,breathiness and irregularity by auditory perceptual assessment using modified GrBAS scale,grades from normal 0 to severe 3

    2. Subjective measurements of patient's assessment of voice severity [Baseline]

      Measurement of scores of Arabic voice handicap index

    3. Objective measurement of vocal pitch [Baseline]

      Measurement of acoustic analysis (fundamental frequency)

    4. Objective measurement of vocal waveform frequency aperiodicity [Baseline]

      Measurement of acoustic analysis (jitter%)

    5. Objective measurement of vocal waveform amplitude aperiodicity [Baseline]

      Measurement of acoq1qustic analysis (shimmer%)

    6. Objective measurement of vocal waveform periodicity to aperiodicity ratio [Baseline]

      Measurement of acoustic analysis :harmonic to noise ratio (db)

    Secondary Outcome Measures

    1. Objective measurements of changes of vocal folds [Baseline]

      Measurement of amplitude,symmetry,periodicity,glottal closure and mucosal wave using video_rhino_laryngo_stroboscopic examination

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Age: any age group may be included in this study.

    2. Gender: both sexes will be included in the study.

    3. 'previously established diagnosis of connective tissue diseases:

    Exclusion Criteria:
    1. history of neurological diseases .

    2. previous history of neck radiation

    3. presence of any other systemic diseases

    4. professional voice users

    5. chronic nonspecific laryngitis like laryngeal scleroma,Tuberculous laryngitis

    6. presence of laryngeal masses

    7. history of neurological diseases .

    8. previous history of neck surgery,intubation.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Hebatullah Badry, Bachelor, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hebatullah badry hanafy mahmoud, Principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04582292
    Other Study ID Numbers:
    • AssiutUhb
    First Posted:
    Oct 9, 2020
    Last Update Posted:
    Oct 9, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hebatullah badry hanafy mahmoud, Principal investigator, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 9, 2020