Frequency of Dysphonia in Asthmatic Patients

August 24, 2018 updated by: University Hospital, Strasbourg, France

Evaluation of the Frequency of Dysphonia by Subjective and Objective Methods in Asthmatic Patients

For many years, it is known that asthmatics have more often dysphonia. However, no study has so far analyzed the reality of dysphonia in asthmatic by making phoniatric tests.

The etiology of dysphonia in asthmatic remains controversial. Indeed, for a long time, inhaled corticosteroids have been considered as responsible for organic abnormalities of the vocal cords. We hypothesized that women with asthma have more often dysphonia, and that dysphonia is rather functional origin.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service de pneumologie, d'allergologie et de pathologie de l'environnement

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women
  • Aged between 18 to 65 years
  • Patient who signed the informed consent.
  • affiliated with a social security system.

Patients with asthma (GINA criteria)

- persistent asthma with inhaled corticosteroids.

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

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
  • the Phonatory Maximum Time
  • Vocal Handicap Index
  • Scale GRBAS of Hirano
  • Videolaryngoscopy
Other: Phoniatric tests
Other Names:
  • - the Phonatory Maximum Time
  • - Vocal Handicap Index
  • - Scale GRBAS of Hirano
  • - Videolaryngoscopy
Experimental: Asthmatic patients
  • The Phonatory Maximum Time
  • Vocal Handicap Index
  • Scale GRBAS of Hirano
  • Videolaryngoscopy
Other: Phoniatric tests
Other Names:
  • - the Phonatory Maximum Time
  • - Vocal Handicap Index
  • - Scale GRBAS of Hirano
  • - Videolaryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of dysphonia. The patient will be considered as having a dysphonia if at least one of the tests (Voice Handicap Index, Rank Rough Breathy Asthenic Strained GRBAS, Quotien Phonatoire QP and Fundamental laryngeal F0) is abnormal
Time Frame: Four week
Four week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Frédéric De Blay, Pr, Pôle de Pathologie Thoracique- Hôpitaux Universitaires Strasbourg

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 (Actual)

December 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 25, 2013

First Submitted That Met QC Criteria

November 25, 2013

First Posted (Estimate)

December 3, 2013

Study Record Updates

Last Update Posted (Actual)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 24, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5517

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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