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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 October 2015
• Main ID: NCT02411370
• Date of registration: 03/04/2015
• Prospective Registration: No
• Primary sponsor: Centre d'Investigation Clinique et Technologique 805
• Public title: Correlation Between Respiratory Impairment and Phonemes Alteration in Dystrophinopathy Patients With Respiratory Failure PHONORESPI
• Date of first enrolment: February 2015
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02411370
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Behavioral: phonetic tests

Primary Outcome(s)

Number and nature of altered phonemes [Time Frame: 5 minutes]

Intelligibility phonetic test [Time Frame: 5 minutes]

Secondary ID(s)

PHONORESPI n°CPP 14079

Source(s) of Monetary Support

Please refer to primary and secondary sponsors