Acoustic and breathing tests for dysarthria after acquired brain injury
Evaluating Dysarthria Through Acoustic and Respiratory Parameters: A Clinical Protocol
This study will see if combining voice recordings, breathing tests, and a clinical speech check can help identify the type and severity of dysarthria in adults after an acquired brain injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Salamanca Academic / other |
| Locations | 1 site (Salamanca, Salamanca) |
| Trial ID | NCT07435155 on ClinicalTrials.gov |
What this trial studies
This is a cross-sectional observational study of about 97–101 adults with acquired brain injury that records voice and speech, measures lung function with spirometry, and performs the Frenchay Dysarthria Assessment-2 adapted to Spanish. All assessments occur at a single baseline visit under standardized conditions to limit fatigue and variability. Acoustic, respiratory, and clinical data will be analyzed together to explore associations between phonatory/respiratory function and dysarthria presence, subtype, and severity. The protocol does not include any treatment or longitudinal follow-up.
Who should consider this trial
Good fit: Adults (18+) with an acquired brain injury such as stroke, traumatic brain injury, or brain tumor who can give consent, have preserved cognition (MMSE ≥ 24), and can complete voice and spirometry tests are ideal candidates.
Not a fit: People with pre-existing voice disorders, chronic respiratory disease, significant hearing loss, additional neurodegenerative disorders, or who cannot complete the testing protocol are unlikely to benefit from the findings.
Why it matters
Potential benefit: If successful, the approach could help speech therapists detect dysarthria earlier and tailor therapy more precisely for adults after brain injury.
How similar studies have performed: Previous work has linked acoustic measures to dysarthria and used spirometry in related contexts, but combining acoustic, respiratory, and FDA-2 clinical measures in adults with ABI is relatively novel and has limited large-scale confirmation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older at the time of enrollment. Diagnosed with acquired brain injury (ABI), including: * Stroke * Traumatic brain injury (TBI) * Brain tumor * Ability to provide written informed consent (or via a legally authorized representative if necessary). * Cognitive function preserved, defined as a Mini-Mental State Examination (MMSE) score ≥ 24. Exclusion Criteria: * History of chronic respiratory diseases, such as chronic obstructive pulmonary disease (COPD) or asthma. * History of hearing impairments that could affect speech evaluation. * Presence of additional neurological or neurodegenerative disorders other than the acquired brain injury. * History of voice disorders or dysphonia prior to the acquired brain injury. * Presence of persistent pharyngeal symptoms, such as mucus, secretions, or foreign body sensation, which may interfere with speech assessment. * Participants unable to comply with the assessment protocol or complete the required sessions. * Presence of apahasia that prevents participation in speech tasks, such as reading, repetition, or spontaneous speech priduction.
Where this trial is running
Salamanca, Salamanca
- University of Salamanca — Salamanca, Salamanca, Spain (Recruiting)
Study contacts
- Principal investigator: Ana-María Martín Nogueras, Investigator/ Profesor — University of Salamanca
- Study coordinator: AHMED ARGOUBI, Speech Language Pathologist
- Email: ahmedargoubi@usal.es
- Phone: +34 652555591
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.