NCT05993364 Efficacy of EFA in Acquired Brain Injury
| NCT ID | NCT05993364 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Don Carlo Gnocchi ETS |
| Condition | Acquired Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-02-19 |
| Primary Completion | 2025-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-02-19 with a primary completion date of 2025-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Acquired brain injury (ABI) is one of the biggest cause of death and disability in the world. Patients with ABI often have difficulties with swallow and breath. The study purpose is to evaluate if the Expiratory Flow Accelerator (EFA) technology has positive effects on the respiratory and swallowing function in patients with acquired brain injury (ABI). Researchers recruit patients at Centro Ettore Spalenza-Fondazione Don Carlo Gnocchi in Rovato, Italy. To partecipate, patients should satisfy certain eligibility criteria; they will not be enrolled if they satisfy exclusion criteria. If a patient can be recruited, researchers conduct the baseline assessment lasting 1 one week. After that, the patient will be randomized to the study or control group. If the patient is in the control group, he will receive a traditional rehabilitation treatment. Otherwise, the patient will receive an additional treatment with the EFA device. Researchers will assess again the patient (with the same procedures of baseline assessment) after 8 weeks of treatment. They want to see if the EFA device could help patients with ABI to improve their health conditions.
Eligibility Criteria
Inclusion Criteria: * Age higher than 18 years old; * Hospitalization after diagnosis of Acquired Brain Injury (both traumatic and vascular) * Levels of Cognitive Functioning Scale (LCFS) score between 1and 5; * Presence of spontaneous breathing, at least during the day Exclusion Criteria: * Need of mechanical ventilation for more than 12 hours a day; * Presence of tracheal stoma not properly healed after the removal of the tracheal cannula.
Contact & Investigator
Luca NC Bianchi, MD
PRINCIPAL INVESTIGATOR
IRCSS Fondazione Don Carlo Gnocchi
Frequently Asked Questions
Who can join the NCT05993364 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acquired Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05993364 currently recruiting?
Yes, NCT05993364 is actively recruiting participants. Contact the research team at rburaschi@dongocchi.it for enrollment information.
Where is the NCT05993364 trial being conducted?
This trial is being conducted at Rovato, Italy.
Who is sponsoring the NCT05993364 clinical trial?
NCT05993364 is sponsored by Fondazione Don Carlo Gnocchi ETS. The principal investigator is Luca NC Bianchi, MD at IRCSS Fondazione Don Carlo Gnocchi. The trial plans to enroll 20 participants.