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
42 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how a speaking valve affects breathing, swallowing, and vocal functions in patients who have a tracheostomy and disturbances of consciousness. The study focuses on participants who do not require mechanical ventilation and are in a state such as unresponsive wakefulness syndrome or minimally conscious state. This research aims to understand if using the speaking valve during respiratory therapy offers benefits in managing breathing and secretions. Participants are randomly assigned to one of two groups: one group receives respiratory physical therapy treatments using the Shiley2 phonate speaking valve connected to their tracheostomy tube for at least 8 sessions over 2 weeks. The other group receives similar respiratory physical therapy without the speaking valve. The study compares these approaches to evaluate differences in breathing and vocal function. During the study, researchers measure changes in oxygen saturation and breathing rate over 15 minutes as primary outcomes. Secondary outcomes include swallowing rate, vocalization presence after 2 weeks, cough rate, and the percentage of patients weaned from the tracheostomy over approximately 6 months. The study involves ongoing assessments to monitor these outcomes and the participant's respiratory function throughout the treatment period and follow-up.
CONDITIONS
Brief 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 must speak Hebrew.
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive respiratory physical therapy treatments with or without the speaking valve device.
At least 8 therapy sessions over 2 weeks
Duration - Approximately 6 months
Participants are monitored for vocalization, cough rate, and weaning from tracheostomy over an average of 6 months.
Periodic assessments during the follow-up period
Trial Site Locations
Total: 1 location
1
Loewenstein Rehabilitation Hospital
Raanana, Israel
Actively Recruiting
Research Team
E
Elena Aidinoff, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here