Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID07587762

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

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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

Monitoring

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

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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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