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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  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.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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