Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices

Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices:A Prospective Cohort Study

The population included in this study consists of tracheostomy patients admitted to the pulmonary department of Beijing Rehabilitation Hospital, undergoing decannulation rehabilitation treatment. Once patient conditions stabilized, they were all transitioned to the decannulation process established by our department in 2018, which utilizes a speaking valve instead of capping.The initial duration for the patient to wear the speaking valve is 30 minutes.The monitoring period for wearable devices is from 1 hour before the initial use of the speaking valve to 1 hour after its removal.Monitored for a total of 2 hours and 30 minutes.Explore the clinical benefits of the speaking valve by comparing the changes in patients' physiological parameters and clinical index metrics before and after using the speaking valve.

Criteria for the successful use of the speaking valve for 30 minutes:

1. Breathing is steady at rest: no apparent dyspnea, chest tightness, or orthopnea, etc.
2. Heart rate, blood pressure, and SpO₂ are all stable overall.SpO₂ reduction from baseline < 5%.
3. No frequent need for emergency sputum suction or indications of sputum blockage while wearing it.

Study Overview

• Status: Recruiting
• Conditions: Tracheostomy; Wearable Devices; Physiological Parameter
• Intervention / Treatment: Other: Tracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutes

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongying Jiang; Phone Number: +8601056981555; Email: 6jhy@163.com
• Study Contact Backup: Name: Bin Zhang; Phone Number: +8618600530758; Email: zbzgzjz@sina.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100144
      • Recruiting
      • Beijing Rehabilitation Hospital, Capital Medical University
      • Contact: 光宇 牛; Phone Number: 86-13681210212; Email: 1245417228@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 90 years≥Age≥18 years;
• Tracheotomy post-operation>48 hours；
• Weaned off mechanical ventilation;
• Clinically stable condition;
• Tolerable for cuff deflation;
• Able to tolerate wearing a speaking valve continuously for 30 minutes;
• Signed informed consent.

Exclusion Criteria:

• Patients with abnormal skin conditions preventing continuous wearing of monitoring devices;
• Inability to tolerate wearing a speaking valve continuously for 30 minutes;
• Interruption of physiological monitoring data;
• Poor quality of physiological monitoring data;
• Recently underwent neck/upper airway surgery (≤48 hours, to avoid airflow impact on the upper airway);
• Severe consciousness disturbance/delirium (RASS score≤-3 or ≥ +2), extreme anxiety/uncooperativeness;
• Total laryngectomy or laryngotracheal separation;
• Age <18 years or >90 years;
• Malignant tumor with an expected survival time ≤6 months;
• The patient or legal representative is unable to sign the informed consent form.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Successfully wore the speaking valve for the first time for 30 minutes.; Inclusion Criteria： Breathing is steady at rest: no apparent dyspnea, chest tightness, or orthopnea, etc.; Heart rate, blood pressure, and SpO₂ are all stable overall.SpO₂ reduction from baseline < 5%.; No frequent need for emergency sputum suction or indications of sputum blockage while wearing it.

Other: Tracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutes; Once patient conditions stabilized, they were all transitioned to the decannulation process established by our department in 2018, which utilizes a speaking valve instead of capping.The initial duration for the patient to wear the speaking valve is 30 minutes.If the patient can tolerate wearing the speaking valve for 30 minutes, they fulfill the inclusion criteria.The monitoring period for wearable devices is from 1 hour before the initial use of the speaking valve to 1 hour after its removal.Monitored for a total of 2 hours and 30 minutes. Physiological parameters recorded prior to wearing the speaking valve served as the baseline.Compare the physiological parameters while wearing the speaking valve and after its removal to investigate the clinical benefits that the speaking valve can provide.To promote the application of speaking valves in future clinical work more effectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
degree of change in oxygen saturation（%）	Previous studies have been concerned that speaking valve placement increases upper airway resistance, thereby inducing dyspnea and hypoxemia in patients. Therefore, we used continuous wearable physiological monitoring devices to observe changes in oxygen saturation before, during, and after the training.	Using wearable biosensors, high-resolution physiological data were continuously collected during three phases: baseline (30 minutes), speaking valve placement period (30 minutes), and recovery period (30 minutes after speaking valve removal).
Temporal rate of change of asymmetric cardiovascular responses and delayed autonomic recovery（percentage change from baseline）	The rate of change (percentage per minute) in asymmetric cardiovascular responses (e.g., heart rate variability indices) and delayed autonomic recovery will be calculated. Physiological data (heart rate, HRV metrics) are continuously collected before, during, and after speaking valve placement. The primary reported value is the slope of change over time, expressed as a percentage relative to baseline, aggregated across all participants using mixed-effects modeling to produce a single mean rate of change	30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
Rate of respiratory phase variation during training（percentage change in phase duration）	The rate of change in respiratory phase variation (e.g., changes in inspiratory/expiratory time proportion) during speaking valve training. Respiratory parameters are continuously recorded. The outcome is the calculated rate of change (percentage per minute) from baseline to the active training period and to the recovery period. A single aggregated value (mean slope) will be derived from all participants using linear mixed models.	30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session

Collaborators and Investigators

• Sponsor: Bin Zhang
• Collaborators: Chinese PLA General Hospital; Capital Medical University
• Investigators: Study Chair: Hongying Jiang, Beijing Rehabilitation Hospital of Capital Medical University, Beijing, China

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: tracheostomy; Wearable Devices; speaking valve; Physiological Parameter
• Other Study ID Numbers: 2026-bjkfyy-SVB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No