NCT07422350

The Effect of Speaking Valve on Physiological Parameters With Wearable Devices

The Effect of Speaking Valve on Physiological Parameters of Tracheostomized Patients With Wearable Devices

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Jingyi Ge · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tracheostomy Decannulation

Timeline

• Start date: 2026-01-31
• Primary completion: 2026-10-20
• Completion: 2026-12-31
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: China