NCT04582292

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

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 9, 2020

Status Verified

October 1, 2020

Enrollment Period

5 months

First QC Date

October 5, 2020

Last Update Submit

October 8, 2020

Conditions

Connective Tissue Diseases

Keywords

Laryngeal manifestation in connective tissue diseases

Outcome Measures

Primary Outcomes (6)

  • 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

    Baseline

  • Subjective measurements of patient's assessment of voice severity

    Measurement of scores of Arabic voice handicap index

    Baseline

  • Objective measurement of vocal pitch

    Measurement of acoustic analysis (fundamental frequency)

    Baseline

  • Objective measurement of vocal waveform frequency aperiodicity

    Measurement of acoustic analysis (jitter%)

    Baseline

  • Objective measurement of vocal waveform amplitude aperiodicity

    Measurement of acoq1qustic analysis (shimmer%)

    Baseline

  • Objective measurement of vocal waveform periodicity to aperiodicity ratio

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

    Baseline

Secondary Outcomes (1)

  • Objective measurements of changes of vocal folds

    Baseline

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cross\_sectional study

You may qualify if:

  • 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:

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

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

    PMID: 16987829BACKGROUND

  • 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.

    PMID: 12110146BACKGROUND

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

    PMID: 1131102BACKGROUND

  • 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.

    PMID: 17974016BACKGROUND

  • 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.

    PMID: 7603711BACKGROUND

  • 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.

    PMID: 15085384BACKGROUND

  • 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.

    PMID: 9779856BACKGROUND

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

    PMID: 834514BACKGROUND

  • 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.

    PMID: 10325555BACKGROUND

  • 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.

    PMID: 17280816BACKGROUND

  • 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.

    PMID: 14442250BACKGROUND

MeSH Terms

Conditions

Connective Tissue Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

  • Hebatullah Badry, Bachelor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Essam eldeen Aref, MD

CONTACT

01099696543essamaref@yahoo.com

Hanan Abdelrasheed, MD

CONTACT

01007954155hanan.abdelrashed2007@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 5, 2020

First Posted

October 9, 2020

Study Start

November 1, 2020

Primary Completion

April 1, 2021

Study Completion

December 1, 2021

Last Updated

October 9, 2020

Record last verified: 2020-10