Efficacy of EFA in Acquired Brain Injury

Recruiting now · Not applicable

Conditions studied: Acquired Brain Injury, Comparative Effectiveness Research, Lung Diseases, Obstructive

In brief

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.

Key facts

Study ID

NCT05993364

Run by

Fondazione Don Carlo Gnocchi ETS

People needed

20

Starts

2024-02-19

Expected to finish

2025-12-01

Last updated by the study team

2024-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Fondazione Don Carlo Gnocchi - Centro Ettore Spalenza — Rovato, BS, Italy (enrolling)

Full record on ClinicalTrials.gov

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