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Connective Tissue DiseasesNCT04582292

Laryngeal Manifestations of Connective Tissue Diseases

An observational study of Connective Tissue Diseases, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Connective Tissue Diseases
How many people
50 participants
Where
No sites listed yet
Study dates
1 Nov 2020to 1 Dec 2021
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Cross_sectional study

Who may be able to join

  • Age: any age group may be included in this study.
  • Gender: both sexes will be included in the study.
  • 'previously established diagnosis of connective tissue diseases:

Who cannot join

  • history of neurological diseases .
  • previous history of neck radiation
  • presence of any other systemic diseases
  • professional voice users
  • chronic nonspecific laryngitis like laryngeal scleroma,Tuberculous laryngitis
  • presence of laryngeal masses
  • history of neurological diseases .
  • previous history of neck surgery,intubation.

Trial locations and contacts

No sites are listed yet.

Essam eldeen Aref, MD contact

01099696543

essamaref@yahoo.com

Hanan Abdelrasheed, MD contact

01007954155

hanan.abdelrashed2007@yahoo.com

About this study

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

Read the 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 .

Keywords
Laryngeal manifestation in connective tissue diseases
Medical subject headings
Connective Tissue Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective measurement of severity of dysphonia connective tissue disease.

    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

    Measured: Baseline

  2. Subjective measurements of patient's assessment of voice severity

    Measurement of scores of Arabic voice handicap index

    Measured: Baseline

  3. Objective measurement of vocal pitch

    Measurement of acoustic analysis (fundamental frequency)

    Measured: Baseline

  4. Objective measurement of vocal waveform frequency aperiodicity

    Measurement of acoustic analysis (jitter%)

    Measured: Baseline

  5. Objective measurement of vocal waveform amplitude aperiodicity

    Measurement of acoq1qustic analysis (shimmer%)

    Measured: Baseline

  6. Objective measurement of vocal waveform periodicity to aperiodicity ratio

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

    Measured: Baseline

Secondary outcomes (1)

  1. Objective measurements of changes of vocal folds

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2020
  2. Study start1 Nov 2020 (estimated)
  3. Primary completion1 Apr 2021 (estimated)
  4. Study completion1 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT04582292
Sponsor's protocol ID
AssiutUhb
Status last verified
Oct 2020
First submitted
5 Oct 2020
Last updated
9 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Gaubitz M. Epidemiology of connective tissue disorders. Rheumatology (Oxford). 2006 Oct;45 Suppl 3:iii3-4. doi: 10.1093/rheumatology/kel282.

    PubMed 16987829

  • Silman AJ, Pearson JE. Epidemiology and genetics of rheumatoid arthritis. Arthritis Res. 2002;4 Suppl 3(Suppl 3):S265-72. doi: 10.1186/ar578. Epub 2002 May 9.

    PubMed 12110146

  • Friedman BA. Rheumatoid nodules of the larynx. Arch Otolaryngol. 1975 Jun;101(6):361-3. doi: 10.1001/archotol.1975.00780350025006.

    PubMed 1131102

  • Upile T, Jerjes W, Sipaul F, Singh S, Hopper C, Wright A, Sandison A. Rheumatoid nodule of the thyrohyoid membrane: a case report. J Med Case Rep. 2007 Oct 31;1:123. doi: 10.1186/1752-1947-1-123.

    PubMed 17974016

  • Woo P, Mendelsohn J, Humphrey D. Rheumatoid nodules of the larynx. Otolaryngol Head Neck Surg. 1995 Jul;113(1):147-50. doi: 10.1016/S0194-59989570160-5.

    PubMed 7603711

  • Van der Goten A. Evaluation of the patient with hoarseness. Eur Radiol. 2004 Aug;14(8):1406-15. doi: 10.1007/s00330-004-2272-x. Epub 2004 Apr 14.

    PubMed 15085384

  • Petty RE, Southwood TR, Baum J, Bhettay E, Glass DN, Manners P, Maldonado-Cocco J, Suarez-Almazor M, Orozco-Alcala J, Prieur AM. Revision of the proposed classification criteria for juvenile idiopathic arthritis: Durban, 1997. J Rheumatol. 1998 Oct;25(10):1991-4. No abstract available.

    PubMed 9779856

  • Jacobs JC, Hui RM. Cricoarytenoid arthritis and airway obstruction in juvenile rheumatoid arthritis. Pediatrics. 1977 Feb;59(2):292-4.

    PubMed 834514

  • Hosako-Naito Y, Tayama N, Niimi S, Aotsuka S, Miyaji M, Oka T, Fujinami M, Kitahara N. Diagnosis and physiopathology of laryngeal deposits in autoimmune disease. ORL J Otorhinolaryngol Relat Spec. 1999 May-Jun;61(3):151-7. doi: 10.1159/000027661.

    PubMed 10325555

  • Hilgert E, Toleti B, Kruger K, Nejedlo I. Hoarseness due to bamboo nodes in patients with autoimmune diseases: a review of literature. J Voice. 2008 May;22(3):343-50. doi: 10.1016/j.jvoice.2006.10.009. Epub 2007 Feb 5.

    PubMed 17280816

  • SCARPELLI DG, McCOY FW, SCOTT JK. Acute lupus erythematosus with laryngeal involvement. N Engl J Med. 1959 Oct 1;261:691-4. doi: 10.1056/NEJM195910012611404. No abstract available.

    PubMed 14442250

Questions about this trial

What is this clinical trial studying?

An observational study of Connective Tissue Diseases, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Essam eldeen Aref, MD (01099696543, essamaref@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective measurement of severity of dysphonia connective tissue disease. (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04582292, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.

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