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Ear-Zap may speed Post-Surgery waking and cut depression risk

NCT ID NCT07610655

Symptom relief Sponsor: Northwestern University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a noninvasive device that gently stimulates a nerve in the ear to help people wake up faster after surgery. Researchers will also see if it reduces confusion and depression after the operation. The study involves 40 adults having lumbar spine surgery.

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

May 2029

An estimate. End dates often move.

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: 1. Aged \> 18 years of age 2. Patients undergoing lumbar surgery for degenerative disc disease or spinal stenosis involving two or more levels 3. Montreal Cognitive Assessment (MoCA) score ≥ 18 - accept mild 4. Ability to use a keyboard 5. Able to understand and communicate in English 6. Be able to consent independently 7. Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study. 8. Must not be involved in any other research intervention study testing neurobehavioral functioning Exclusion Criteria: 1. Age \< 18 years of age 2. History of vagotomy (cutting the vagus nerve) 3. History of bradycardia, heart block, prolonged QT syndrome, brugada syndrome, heart failure with ejection fraction less than 35% and/or New York Heart Association symptoms 4. MoCA \< 18 5. History of seizure disorder or intracranial hemorrhage 6. Patients with carotid stenosis 7. Patients with aneurysms 8. Other neurological diagnoses or a diagnosis of severe psychiatric disorder (e.g., psychosis) or a reported childhood learning disability 9. Pregnancy, breastfeeding 10. Active addiction history 11. ECG adhesive allergy 12. Severe aphasia, preventing subject from understanding the protocol and giving written consent 13. Patients will be excluded postoperatively if there is neck swelling at the proposed site of left tcVNS.

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction delirium Depression depressive disorder Emergence Delirium lumbar disk degenerative disorder spinal stenosis

As listed by the trial registrant

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

Cognitive impairment Depression Post operative delirium Vagus nerve stimulation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Northwestern University Feinberg School of Medicine

    RECRUITING

    Chicago, Illinois, 60611, United States

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Other studies related to the condition(s) this trial covers.