Actively Recruiting
Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices A Prospective Cohort Study
Led by Bin Zhang · Updated on 2026-05-14
120
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
B
Bin Zhang
Lead Sponsor
C
Capital Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the clinical benefits of using speaking valves in patients with tracheostomies who are admitted to the pulmonary department and undergoing decannulation rehabilitation. The study focuses on patients who are clinically stable and have been weaned off mechanical ventilation. It aims to compare changes in physiological parameters and clinical index metrics before and after using the speaking valve to better understand its effects during the decannulation process. The study involves having patients wear a speaking valve continuously for 30 minutes, which replaces the traditional capping method used in decannulation. The monitoring period with wearable biosensors covers 1 hour before the valve use, the 30-minute valve wearing period, and 1 hour after removal, totaling 2 hours and 30 minutes. Researchers will collect continuous, high-resolution physiological data during baseline, valve wear, and recovery phases to evaluate oxygen saturation changes, cardiovascular responses, and respiratory phase variations. Participants will be closely observed during the valve wearing process to ensure stable breathing, heart rate, blood pressure, and oxygen saturation without significant distress or frequent sputum blockage. The study measures the degree of change in oxygen saturation, cardiovascular asymmetry, autonomic recovery, and respiratory phase variation. The total monitoring and data collection time is about two and a half hours, and safety and tolerability are carefully tracked throughout the study period.
CONDITIONS
Brief Title
Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 90 years
- Tracheotomy performed more than 48 hours prior
- Weaned off mechanical ventilation
- Clinically stable condition
- Able to tolerate cuff deflation
- Able to wear a speaking valve continuously for 30 minutes
- Signed informed consent
You will not qualify if you...
- Abnormal skin conditions preventing continuous wearing of monitoring devices
- Unable to tolerate wearing a speaking valve continuously for 30 minutes
- Interruption or poor quality of physiological monitoring data
- Neck or upper airway surgery within the past 48 hours
- Severe consciousness disturbance, delirium, extreme anxiety, or uncooperativeness
- Total laryngectomy or laryngotracheal separation
- Age under 18 years or over 90 years
- Malignant tumor with expected survival of 6 months or less
- Unable to sign informed consent or legal representative unable to sign
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 30 minutes
Participants wear a speaking valve for 30 minutes to assess their tolerance and physiological response.
1 in-person session for wearing the speaking valve and monitoring physiological parameters
Duration - 2 hours 30 minutes
Physiological parameters are monitored using wearable devices starting 1 hour before wearing the speaking valve, during the 30 minutes of wearing, and continuing for 1 hour after removal to evaluate clinical benefits.
Trial Site Locations
Total: 1 location
1
Beijing Rehabilitation Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100144
Actively Recruiting
Research Team
B
Bin Zhang
H
Hongying Jiang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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