TracheostomyNCT05482022
Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.
A study testing Shiley™ phonate speaking valve in people with Tracheostomy, run by Loewenstein Hospital at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy
- What is being tested?
- Shiley™ phonate speaking valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2022to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- airway stenosis / inflammation.
- oxygen saturation <90%.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Loewenstein Rehabilitation Hospital
Raanana
Sara Lipkin
About this study
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
- Being tested
- Shiley™ phonate speaking valve, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shiley™ phonate speaking valveDevice
Also called speaking valve
The device connects to the tracheostomy tube. Usually used to aid vocalization.
controlOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| speaking valve | Experimental | Respiratory physical therapy treatments conducted using a speaking valve for 2 weeks (at least 8 treatments). Receives: Device: Shiley™ phonate speaking valve |
| control | Other | Respiratory physical therapy treatments conducted without using a speaking valve . Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline oxygen saturation
at physical therapy sessions
Measured: 15 minutes
change from baseline breathing rate
at physical therapy sessions
Measured: 15 minutes
Secondary outcomes (4)
rate of swallowing
during a physical therapy session
Measured: 15 minutes
percentage of participants presenting vocalization
occurrence of vocalization at the respiratory physical therapy sessions.
Measured: 2 weeks
cough rate
the ratio of respiratory physical therapy sessions eliciting cough.
Measured: 2 weeks
percentage of patients weaned from tracheostomy
whether or not decannulation was successfully performed during rehabilitation.
Measured: through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Aug 2022
- Primary completion27 Mar 2025
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, elena eidinov, Loewenstein Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482022
- Sponsor's protocol ID
- 0027-21-LOE
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2022
- Last updated
- 14 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.
- ClinicalTrials.gov ID
- NCT05482022
- Acronym / sponsor ID
- 0027-21-LOE
- Conditions
- Tracheostomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| speaking valve | Experimental | Device: Shiley™ phonate speaking valveRespiratory physical therapy treatments conducted using a speaking valve for 2 weeks (at least 8 treatments). |
| control | Other | Other: controlRespiratory physical therapy treatments conducted without using a speaking valve . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- airway stenosis / inflammation.
- oxygen saturation <90%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shiley™ phonate speaking valveAlso: speaking valveThe device connects to the tracheostomy tube. Usually used to aid vocalization. | Device | speaking valve |
| controlno intervention | Other | control |
Primary outcome
change from baseline oxygen saturation
Time frame: 15 minutes
at physical therapy sessions
change from baseline breathing rate
Time frame: 15 minutes
at physical therapy sessions
4 secondary outcomes
rate of swallowing
Time frame: 15 minutes
percentage of participants presenting vocalization
Time frame: 2 weeks
cough rate
Time frame: 2 weeks
percentage of patients weaned from tracheostomy
Time frame: through study completion, an average of 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shiley™ phonate speaking valve in people with Tracheostomy, run by Loewenstein Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Aidinoff, MD (972-9-7654897, aidinofe@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline oxygen saturation (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.