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

Last updated: August 10, 2025
Sponsor: Loewenstein Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ear, Nose, And Throat (Ent) Surgeries

Treatment

Shiley™ phonate speaking valve

control

Clinical Study ID

NCT05482022
0027-21-LOE
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 airwaygranulation, MarianJoy scale score: 1-3.

  • the legal guardian speaks Hebrew.

Exclusion

Exclusion Criteria:

  • airway stenosis / inflammation.

  • oxygen saturation <90%.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Shiley™ phonate speaking valve
Phase:
Study Start date:
August 01, 2022
Estimated Completion Date:
January 15, 2026

Connect with a study center

  • Loewenstein Rehabilitation Hospital

    Ra'anana,
    Israel

    Active - Recruiting

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