- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04582292
Laryngeal Manifestations of Connective Tissue Diseases
October 8, 2020 updated by: Hebatullah badry hanafy mahmoud, Assiut University
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
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Essam eldeen Aref, MD
- Phone Number: 01099696543
- Email: essamaref@yahoo.com
Study Contact Backup
- Name: Hanan Abdelrasheed, MD
- Phone Number: 01007954155
- Email: hanan.abdelrashed2007@yahoo.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Cross_sectional study
Description
Inclusion Criteria:
- 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:
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective measurement of severity of dysphonia connective tissue disease.
Time Frame: 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
|
Baseline
|
Subjective measurements of patient's assessment of voice severity
Time Frame: Baseline
|
Measurement of scores of Arabic voice handicap index
|
Baseline
|
Objective measurement of vocal pitch
Time Frame: Baseline
|
Measurement of acoustic analysis (fundamental frequency)
|
Baseline
|
Objective measurement of vocal waveform frequency aperiodicity
Time Frame: Baseline
|
Measurement of acoustic analysis (jitter%)
|
Baseline
|
Objective measurement of vocal waveform amplitude aperiodicity
Time Frame: Baseline
|
Measurement of acoq1qustic analysis (shimmer%)
|
Baseline
|
Objective measurement of vocal waveform periodicity to aperiodicity ratio
Time Frame: Baseline
|
Measurement of acoustic analysis :harmonic to noise ratio (db)
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective measurements of changes of vocal folds
Time Frame: Baseline
|
Measurement of amplitude,symmetry,periodicity,glottal closure and mucosal wave using video_rhino_laryngo_stroboscopic examination
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hebatullah Badry, Bachelor, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gaubitz M. Epidemiology of connective tissue disorders. Rheumatology (Oxford). 2006 Oct;45 Suppl 3:iii3-4. doi: 10.1093/rheumatology/kel282. Erratum In: Rheumatology (Oxford). 2008 Feb;47(2):234-5.
- 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.
- Friedman BA. Rheumatoid nodules of the larynx. Arch Otolaryngol. 1975 Jun;101(6):361-3. doi: 10.1001/archotol.1975.00780350025006.
- 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.
- 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.
- 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.
- 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.
- Jacobs JC, Hui RM. Cricoarytenoid arthritis and airway obstruction in juvenile rheumatoid arthritis. Pediatrics. 1977 Feb;59(2):292-4.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2020
Primary Completion (Anticipated)
April 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
October 5, 2020
First Submitted That Met QC Criteria
October 8, 2020
First Posted (Actual)
October 9, 2020
Study Record Updates
Last Update Posted (Actual)
October 9, 2020
Last Update Submitted That Met QC Criteria
October 8, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AssiutUhb
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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