Correlation Between Respiratory Impairment and Phonemes Alteration in Dystrophinopathy Patients With Respiratory Failure (PHONORESPI)

October 14, 2015 updated by: Centre d'Investigation Clinique et Technologique 805

Communication is essential for patients quality of life because it impact on patients care quality. Neuromuscular diseases, caracterised by motor damages, hinder non-verbal communication of the patient. Therefore, speech must to be functional.

However, correlation between respiratory failure and voice quality is not very well known. The aim of the study is to search a link between respiratory failure and speech impairment in patients with neuromuscular diseases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

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
    • Hauts-de-Seine
      • Garches, Hauts-de-Seine, France, 92380
        • Hôpital Raymond-Poincaré

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Dystrophinopathy patients with limitive respiratory failure.

Description

Inclusion Criteria:

  • Respiratory autonomy at least 1 hour per day
  • Stable patient during the study
  • Patient with education at least up to secondary school

Exclusion Criteria:

  • Refusal to participate
  • Inability to cooperate
  • Tracheostomized patients
  • Mechanic ventilation - dependant patients
  • Respiratory autonomy lower than 1 hour per day
  • Patients with hemodynamic instabillity
  • Patient insured under the French social security system

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intelligibility phonetic test
Time Frame: 5 minutes
5 minutes
Number and nature of altered phonemes
Time Frame: 5 minutes
5 minutes

Collaborators and Investigators

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

Sponsor

Centre d'Investigation Clinique et Technologique 805

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

February 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 3, 2015

First Submitted That Met QC Criteria

April 3, 2015

First Posted (Estimate)

April 8, 2015

Study Record Updates

Last Update Posted (Estimate)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • PHONORESPI n°CPP 14079

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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