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Could a simple ear probe replace invasive brain pressure monitoring?

NCT ID NCT01685476

Diagnosis Sponsor: University Hospital, Clermont-Ferrand Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests whether a new device, placed gently in the ear canal, can accurately measure pressure inside the skull without surgery. The device works by detecting tiny changes in inner-ear activity that reflect pressure shifts in the brain. It will be compared to the standard invasive method in 20 adults who already require intracranial pressure monitoring due to conditions like traumatic brain injury or stroke. If proven reliable, this approach could offer a safer, simpler way to track brain pressure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Echodia® hand-held device that measures cochlear activity via a probe in the ear canal
What this could lead to
If successful, this could provide a safe, non-invasive way to monitor intracranial pressure, reducing infection risks and enabling longer monitoring.
What could go wrong
This is a small early-stage validation study, so the device may not prove accurate enough to replace invasive methods, and individual ear differences could affect readings.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

20 people

The number who actually took part.

Start date

Jan 2011

Finished

Nov 2012

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 years and older

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: * Patients with intracranial pressure monitoring * Age greater than 18 * consent form signed by a close relative (husband, wife, children, legal guardian), * Patient covered under French social security or being a beneficiary of such a regime under the terms of the Act of August 9, 2004 Exclusion Criteria: * Refusal by the close relative to sign a consent form * Impossibility of electrophysiological measurements (pathophysiological reason) * Technical troubles with the device * Patient uncovered under French social security

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic intracerebral hemorrhage Intracranial Hemorrhages intracranial hypertension stroke disorder traumatic brain injury

As listed by the trial registrant

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

Intracranial hemorrhages Intracranial pressure Stroke Traumatic brain injury

Contacts and locations

Locations

  • Chu Clermont Ferrand

    Clermont-Ferrand, 63003, France

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