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

NCT05482022 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-14

No results posted yet for this 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.

Conditions

  • Tracheostomy

Interventions

DEVICE

Shiley™ phonate speaking valve

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

OTHER

control

no intervention

Sponsors & Collaborators

  • Loewenstein Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2025-03-27
Completion
2026-01-15
FDA Device
Yes

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05482022 on ClinicalTrials.gov