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NCT Number: NCT05482022

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

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.

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Key information

Conditions

Tracheostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loewenstein Rehabilitation Hospital

Raanana, Israel

Location status: Recruiting

Location contact

Sara Lipkin

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 airway granulation, MarianJoy scale score: 1-3.
  • the legal guardian speaks Hebrew.

Exclusion criteria

  • airway stenosis / inflammation.
  • oxygen saturation <90%.

Treatment and study plan

Shiley™ phonate speaking valve

Device

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

Other names: speaking valve

Control

Other

no intervention

Primary outcomes

  1. change from baseline oxygen saturation

    Time frame: 15 minutes

    at physical therapy sessions

  2. change from baseline breathing rate

    Time frame: 15 minutes

    at physical therapy sessions

Secondary outcomes

  1. rate of swallowing

    Time frame: 15 minutes

    during a physical therapy session

  2. percentage of participants presenting vocalization

    Time frame: 2 weeks

    occurrence of vocalization at the respiratory physical therapy sessions.

  3. cough rate

    Time frame: 2 weeks

    the ratio of respiratory physical therapy sessions eliciting cough.

  4. percentage of patients weaned from tracheostomy

    Time frame: through study completion, an average of 6 months.

    whether or not decannulation was successfully performed during rehabilitation.

Other outcomes

  1. number of desaturation events

    Time frame: 2 weeks

    oxygen levels decrease below 90% or by 3% from baseline during respiratory physical therapy sessions.

  2. number of respiratory physical therapy sessions

    Time frame: 2 weeks

    the number of respiratory physical therapy sessions given to a participant

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Aidinoff, MD

CONTACT

[email protected]

972-9-7654897

Sponsors and collaborators

Lead sponsor

Loewenstein Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 1, 2022
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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