Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05482022

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

180 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 is a Hebrew speaker.
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Loewenstein Rehabilitation Hospital

Raanana, Israel

Actively Recruiting

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Research Team

E

Elena Aidinoff, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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