During the Medical Appointment, the Speech Therapist Will Perform Phonetic TestsPHONORESPINCT02411370
Correlation Between Respiratory Impairment and Phonemes Alteration in Dystrophinopathy Patients With Respiratory Failure
An observational study of During the Medical Appointment, the Speech Therapist Will Perform Phonetic Tests, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- During the Medical Appointment, the Speech Therapist Will Perform Phonetic Tests
- What is being tested?
- phonetic tests
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dystrophinopathy patients with limitive respiratory failure.
Who may be able to join
- Respiratory autonomy at least 1 hour per day
- Stable patient during the study
- Patient with education at least up to secondary school
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- phonetic tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phonetic testsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Intelligibility phonetic test
Measured: 5 minutes
Number and nature of altered phonemes
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for During the Medical Appointment, the Speech Therapist Will Perform Phonetic TestsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411370
- Sponsor's protocol ID
- PHONORESPI n°CPP 14079
- Acronym
- PHONORESPI
- Status last verified
- Oct 2015
- First submitted
- 3 Apr 2015
- Last updated
- 15 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Respiratory Impairment and Phonemes Alteration in Dystrophinopathy Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT02411370
- Acronym / sponsor ID
- PHONORESPI / PHONORESPI n°CPP 14079
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dystrophinopathy patients with limitive respiratory failure.
Key inclusion criteria (3 listed)
- Respiratory autonomy at least 1 hour per day
- Stable patient during the study
- Patient with education at least up to secondary school
Key exclusion criteria (7 listed)
- Refusal to participate
- Inability to cooperate
- Tracheostomized patients
- Mechanic ventilation - dependant patients
- Respiratory autonomy lower than 1 hour per day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phonetic tests | Behavioural | – |
Primary outcome
Intelligibility phonetic test
Time frame: 5 minutes
Number and nature of altered phonemes
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of During the Medical Appointment, the Speech Therapist Will Perform Phonetic Tests, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intelligibility phonetic test (time frame: 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2015.