Speaking valve to help breathing, swallowing, and voice for people with a tracheostomy
Official title: Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.
Run by Loewenstein Hospital · NCT05482022 · Data updated 2026-11-12
This project will try a speaking valve during respiratory therapy to see if it helps breathing, secretion control, swallowing, and vocal function in people with a tracheostomy who are not on mechanical ventilation and have disorders of consciousness.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Loewenstein Hospital Academic / other |
| Locations | 1 site (Raanana) |
| Status | Recruiting |
| Started | August 1, 2022 |
| Main results expected | March 27, 2025 |
| Study ends | January 15, 2026 |
| Registry record updated | August 14, 2025 |
| Trial ID | NCT05482022 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with tracheostomy after traumatic or non‑traumatic brain injury who are in an unresponsive wakefulness syndrome or minimally conscious state, not mechanically ventilated, with good vocal cord mobility and a Hebrew‑speaking legal guardian are ideal candidates.
✕Probably not a fit
Patients with airway stenosis or inflammation, oxygen saturation under 90%, poor vocal cord mobility, or who require mechanical ventilation are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study will apply a Shiley™ phonate speaking valve during respiratory physical therapy sessions and compare outcomes against a control condition in patients with tracheostomy after brain injury. Eligible participants are in unresponsive wakefulness syndrome or a minimally conscious state, are not mechanically ventilated, and pass a fiber-optic exam showing good vocal cord mobility and no airway granulation (MarianJoy score 1-3). Key exclusions include airway stenosis or inflammation and oxygen saturation below 90%. The trial is single-center at Loewenstein Rehabilitation Hospital and will monitor breathing, secretion management, swallowing, and vocal function during therapy sessions.
Why it matters
Potential benefit: If successful, using a speaking valve during therapy could improve breathing, secretion clearance, swallowing safety, and vocal function, potentially reducing respiratory complications and easing day-to-day care for people with tracheostomy.
How similar studies have gone: Speaking valves have shown benefit for subglottic pressure, secretion management, and swallowing in some prior studies of tracheostomized patients, but evidence specifically in those with disorders of consciousness is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * brain injury (traumatic/non-traumatic). * tracheostomy. * unresponsive wakefulness syndrome or minimally conscious state. * fiber optic examination as follows: good mobilization of the vocal cords. No airway granulation, MarianJoy scale score: 1-3. * the legal guardian speaks Hebrew. Exclusion Criteria: * airway stenosis / inflammation. * oxygen saturation \<90%.
Where it's running
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Loewenstein Rehabilitation Hospital
Raanana, Israel Recruiting
Study contacts
- Study coordinator: Elena Aidinoff, MD
- Email: aidinofe@clalit.org.il
- Phone: 972-9-7654897
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Incremental Instrumental Dead Space vs Capping Trial Before Removing a Tracheostomy
This study tests whether adding extra tubing to the ventilator circuit (without blocking the tube) helps decide when a patient is ready to breathe on their own after a tracheostomy better than the standard capping trial.
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Structured education for families of patients with tracheostomy in the ICU
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Use of invasive home ventilation in Denmark
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-
Predicting airway problems in children with tracheostomies using caregiver and pediatrician reports.
We will see if symptoms reported by caregivers or pediatricians can predict airway complications found during routine surveillance endoscopy in children with tracheostomies.
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Using a speaking valve and transtracheal end‑expiratory pressure to predict upper airway openness
This trial tests whether using a speaking valve together with a transtracheal end‑expiratory pressure (TTPEE) measurement can tell if the upper airway is open in people with prolonged tracheostomies.
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Feeding problems and quality of life in children with a tracheostomy tube
The team will see if feeding and swallowing problems are linked to how children with tracheostomy tubes and their parents rate the child's quality of life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.