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

Recruiting now · Not applicable

Conditions studied: Tracheostomy

In brief

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.

Key facts

Study ID

NCT05482022

Run by

Loewenstein Hospital

People needed

30

Starts

2022-08-01

Expected to finish

2026-01-15

Last updated by the study team

2025-08-14

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• airway stenosis / inflammation.
• oxygen saturation <90%.

Where it is running

• Loewenstein Rehabilitation Hospital — Raanana, Israel (enrolling)

Full record on ClinicalTrials.gov

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