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Wearable tech tracks speaking valve benefits in tracheostomy patients

NCT ID NCT07587762

Knowledge-focused Sponsor: Bin Zhang Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study looks at how a speaking valve affects breathing and heart rate in people with a tracheostomy who are learning to breathe without the tube. About 120 adults will wear sensors before, during, and after using the valve for 30 minutes. The goal is to see if the valve is safe and helpful by tracking oxygen levels and heart patterns.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

120 people

The number who actually took part.

Started

Apr 2026

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Physiological parameter Tracheostomy Wearable devices

Contacts and locations

Locations

  • Beijing Rehabilitation Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100144, China

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