RecruitingNot ApplicableNCT05482022

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


Sponsor

Loewenstein Hospital

Enrollment

30 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how a special one-way speaking valve affects breathing, swallowing, and voice in patients who have a tracheostomy (a breathing tube in the neck) after a brain injury. The goal is to understand whether using the valve helps these functions improve. You may be eligible if: - You have had a brain injury (traumatic or non-traumatic) - You have a tracheostomy - You are in a state of unresponsive wakefulness or minimally conscious state - Fiber optic examination shows good vocal cord movement and no airway growths (MarianJoy scale score 1–3) - Your legal guardian speaks Hebrew You may NOT be eligible if: - You have airway narrowing or inflammation - Your blood oxygen level is below 90% Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEShiley™ phonate speaking valve

The device connects to the tracheostomy tube. Usually used to aid vocalization.

OTHERcontrol

no intervention


Locations(1)

Loewenstein Rehabilitation Hospital

Raanana, Israel

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NCT05482022


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