The Effect of Speaking Valve on Physiological Parameters With Wearable Devices (Effect of SV)

February 12, 2026 updated by: Jingyi Ge

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

To explore the effect of speaking valves on physiological parameters of tracheostomized patients with wearable devices.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100043
        • Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China
        • Contact:
          • Hong ying Jiang
          • Phone Number: +8601056981555
          • Email: 6jhy@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Population:Tracheostomy patients in a rehabilitation hospital undergoing pre-decannulation rehabilitation

Description

Inclusion Criteria:

  1. Patient is not receiving mechanical ventilation.
  2. Tolerates cuff deflation.
  3. Upper airway patency is good, TTP < 10 cmH2O.
  4. Hemodynamically stable, no organ failure, and no sepsis, Pulmonary infection is controlled.
  5. PaCO2<60 mmHg.

Exclusion Criteria:

  1. Cannot tolerate deflation balloon.
  2. Severe upper airway obstruction
  3. Unstable vital signs.
  4. Thick secretions, compromised airway protection.
  5. PaCO2 ≥60 mmHg.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Tolerance Cohort
Tolerance group: Successfully wears a speaking valve for the predefined time threshold (first wearing time = 30 minutes), with a Borg dyspnea score ≤ 3, and no significant CO₂ retention (PaCO₂ < 60 mmHg).
Intolerance Cohort
Intolerance group: occurrence of any of the following during the 30-minute wearing period-marked increase in subjective dyspnea score; need for premature speaking valves removal; sustained SaO2 decrease ≥3%; severe or persistent cough; decompensated respiratory acidosis or PaCO2 ≥ 60 mmHg.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of differences in key physiological parameters between two patient groups
Time Frame: Specified assessment window:From 1 hour before initiation of speaking valve use to 1 hour after speaking valve removal (wearable devices monitoring period).
Primary endpoint: Whether the tracheostomy patient's first use of a speaking valve is successful,duration of use 30 minutes.Primary Objectives:Data from 120 patients were collected using wearable devices,including respiratory rate(RR),heart rate(HR),fingertip blood oxygen saturation(SaO₂),respiratory movement amplitude(RMA),etc.RR and HR refer to the average respiratory and heart rates per minute during monitoring,respectively(breaths/min,beats/min).SaO₂ represents the average oxygen saturation recorded during monitoring(%).RMA means the average thoracic respiratory movement amplitude during monitoring(mm).This study aims to identify factors that can predict successful tolerance of the speaking valve, enhance the decannulation process focused on the "speaking valve," and increase the the success rate of decannulation.
Specified assessment window:From 1 hour before initiation of speaking valve use to 1 hour after speaking valve removal (wearable devices monitoring period).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jingyi Ge

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chinese PLA General Hospital
Peking University Cancer Hospital & Institute
Beijing Rehabilitation Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-bjkfyy-twdmp-svt

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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