Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:46 AM
Study NCT ID:
NCT07422350
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2025-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Speaking Valve on Physiological Parameters With Wearable Devices
Sponsor:
Jingyi Ge
Organization:
Study Overview
Official Title:
The Effect of Speaking Valve on Physiological Parameters of Tracheostomized Patients With Wearable Devices
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Effect of SV
Brief Summary:
To explore the effect of speaking valves on physiological parameters of tracheostomized patients with wearable devices.
Detailed Description:
A speaking valve (such as the common one-way valve/Passy-Muir type) is a one-way device attached to the external opening of a tracheostomy tube: the valve opens during inhalation, allowing air to flow in through the tracheostomy tube; it closes during exhalation, directing airflow upwards through the glottis and out through the mouth and nose, thereby restoring upper airway exhalation, vibrating the vocal cords to produce sound, and enhancing functions such as swallowing, smell, taste, and secretion clearance. This study aims to gather physiological parameter data using non-invasive wearable devices during speaking valve use, compare the differences between before and after wearing speaking valve.It also compares key physiological parameters between the group that can tolerate the speaking valve and the group that cannot. Identify objective indicators associated with successful tolerance.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: