Physiological ParameterNCT07587762
Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices
A study testing Tracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutes in people with Physiological Parameter and Wearable Devices, run by Bin Zhang at 1 site in China.
Trial summary
The population included in this study consists of tracheostomy patients admitted to the pulmonary department of Beijing Rehabilitation Hospital, undergoing decannulation rehabilitation treatment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Physiological Parameter, Wearable Devices, Tracheostomy
- What is being tested?
- Tracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Rehabilitation Hospital, Capital Medical University
Beijing, Beijing Municipality, 100144
About this study
Official title: 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:
- 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.
- Conditions
- Physiological Parameter, Wearable Devices, Tracheostomy
- Being tested
- Tracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutes
- Keywords
- speaking valve, Wearable Devices, tracheostomy, Physiological Parameter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Successfully wore the speaking valve for the first time for 30 minutes. | Experimental | Inclusion Criteria：
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. Receives: Other: Tracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start16 Apr 2026
- Primary completion30 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological ParameterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bin Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Medical University, Chinese PLA General Hospital
- Responsible party
- Sponsor-investigator, Bin Zhang, Capital Medical University
- Investigators
- Hongying Jiang, Study chair, Beijing Rehabilitation Hospital of Capital Medical University, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587762
- Sponsor's protocol ID
- 2026-bjkfyy-SVB
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices:A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07587762
- Acronym / sponsor ID
- 2026-bjkfyy-SVB
- Conditions
- Physiological Parameter, Wearable Devices, Tracheostomy
- Keywords
- speaking valve, Wearable Devices, tracheostomy, Physiological Parameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bin ZhangUniversity, hospital or other
- Collaborators
- Capital Medical University, Chinese PLA General Hospital
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Successfully wore the speaking valve for the first time for 30 minutes. | Experimental | Other: Tracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutesInclusion Criteria： 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 90 years≥Age≥18 years;
- Tracheotomy post-operation>48 hours；
- Weaned off mechanical ventilation;
- Clinically stable condition;
- Tolerable for cuff deflation;
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutesOnce 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 | Other | Successfully wore the speaking valve for the first time for 30 minutes. |
Primary outcome
degree of change in oxygen saturation（%）
Time frame: 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).
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.
Temporal rate of change of asymmetric cardiovascular responses and delayed autonomic recovery（percentage change from baseline）
Time frame: 30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
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
Rate of respiratory phase variation during training（percentage change in phase duration）
Time frame: 30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Physiological Parameter
Not yet recruitingObservational study
Predicting Success of Decannulation Using Wearable-derived Physiology
Tracheostomy Decannulation, Physiological Parameter
Recruiting
Progressive Relaxation Exercises Before Mobilization:Effects on Pain, Anxiety and Physiologic Parameters CABG Patients
Pain, Anxiety
Recruiting
The Effect of Virtual Reality and Eye Mask During Dressing After CABG Surgery
CABG, Physiological Parameter
RecruitingObservational study
The Collagen Factors of Rapid Progression of Keratoconus in Children.
Keratoconus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongying Jiang study chair
Beijing Rehabilitation Hospital of Capital Medical University, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutes in people with Physiological Parameter and Wearable Devices, run by Bin Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of change in oxygen saturation（%） (time frame: 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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.