Speaking valve to help breathing, swallowing, and voice for people with a tracheostomy

Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Loewenstein Hospital (Academic / other)
• Locations: 1 site (Raanana)
• Trial ID: NCT05482022 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Raanana

• Loewenstein Rehabilitation Hospital — Raanana, Israel (Recruiting)

Study contacts

• Study coordinator: Elena Aidinoff, MD

Conditions Tracheostomy