Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.
NCT ID: NCT05482022
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2022-08-01
2026-01-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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speaking valve
Respiratory physical therapy treatments conducted using a speaking valve for 2 weeks (at least 8 treatments).
Shiley™ phonate speaking valve
The device connects to the tracheostomy tube. Usually used to aid vocalization.
control
Respiratory physical therapy treatments conducted without using a speaking valve .
control
no intervention
Interventions
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Shiley™ phonate speaking valve
The device connects to the tracheostomy tube. Usually used to aid vocalization.
control
no intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* oxygen saturation \<90%.
18 Years
ALL
No
Sponsors
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Loewenstein Hospital
OTHER
Responsible Party
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elena eidinov
Head of Intensive Care for Consciousness Rehabilitation Department
Locations
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Loewenstein Rehabilitation Hospital
Raanana, , Israel
Countries
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Central Contacts
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Facility Contacts
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Sara Lipkin
Role: primary
Other Identifiers
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0027-21-LOE
Identifier Type: -
Identifier Source: org_study_id
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