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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02411370
Other study ID # PHONORESPI n°CPP 14079
Secondary ID
Status Completed
Phase N/A
First received April 3, 2015
Last updated October 14, 2015
Start date February 2015
Est. completion date September 2015

Study information

Verified date October 2015
Source Centre d'Investigation Clinique et Technologique 805
Contact n/a
Is FDA regulated No
Health authority France : CPPFrance : CCTIRS
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms

  • During the Medical Appointment, the Speech Therapist Will Perform Phonetic Tests

Intervention

Behavioral:
phonetic tests


Locations

Country Name City State
France Hôpital Raymond-Poincaré Garches Hauts-de-Seine

Sponsors (1)

Lead Sponsor Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intelligibility phonetic test 5 minutes Yes
Primary Number and nature of altered phonemes 5 minutes Yes