Trials / Recruiting
RecruitingNCT05482022
Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Loewenstein Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Shiley™ phonate speaking valve | The device connects to the tracheostomy tube. Usually used to aid vocalization. |
| OTHER | control | no intervention |
Timeline
- Start date
- 2022-08-01
- Primary completion
- 2025-03-27
- Completion
- 2026-01-15
- First posted
- 2022-08-01
- Last updated
- 2025-08-14
Locations
1 site across 1 country: Israel
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05482022. Inclusion in this directory is not an endorsement.