Actively Recruiting
Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.
Led by Loewenstein Hospital · Updated on 2025-08-14
30
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Speaking valve seems to have a beneficial influence on breathing and secretion management in certain patients with tracheostomy. The investigators plan to use a speaking valve during respiratory physical therapy sessions in participants with disturbances of consciousness, who have a tracheostomy, with no need of a mechanical ventilation.
CONDITIONS
Official Title
Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Brain injury (traumatic or non-traumatic).
- Presence of a tracheostomy.
- Diagnosis of unresponsive wakefulness syndrome or minimally conscious state.
- Fiber optic examination showing good vocal cord movement, no airway granulation, and MarianJoy scale score between 1 and 3.
- Legal guardian is a Hebrew speaker.
You will not qualify if you...
- Airway stenosis or inflammation.
- Oxygen saturation less than 90%.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Loewenstein Rehabilitation Hospital
Raanana, Israel
Actively Recruiting
Research Team
E
Elena Aidinoff, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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