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Mystery device trial: what we know so far

NCT ID NCT07195292

Knowledge-focused Sponsor: Toivoa Inc 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 9 times

Summary

This trial is testing a device that has not been approved by the U.S. FDA. The purpose is to gather information about how the device works in people. Participants will be monitored for safety and any effects. The study is still ongoing, and details about who can join are not yet public.

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 200 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

22 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: * Provision of signed and dated informed consent form * Presence of self-reported hearing or mobility disability * Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study * Male or female, age 22 years or older * A score of 17 or higher on the HAM-D * Clinical diagnosis of depression based on DSM-5 diagnostic criteria * Willingness to adhere to the Toivoa-002 or sham regimen once per week, including scheduling and weekly meetings with coaches * Access to necessary resources for participating in a technology-based intervention (e.g., Android phone, iPhone, iPad, internet access) * Treatment stability (no changes in psychotropic medication or psychotherapy treatment in the 30 days prior to study entry) * Able to read and speak English fluently * Resident of the United States and living in the United States for the duration of the trial Exclusion Criteria: * Medical diagnosis of psychotic disorder or bipolar disorder * Participation in another treatment trial at the time of study * Substance use disorder in the past 12 months (excluding tobacco) * Suicide attempt in the past year or elevated suicide risk other than passive ideation (i.e., endorsing items reflecting intent, identifying means, suicide planning, or suicide-related preparations). * Currently pregnant, breastfeeding, or planning to become pregnant during the treatment period

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Conditions

The condition(s) this trial relates to.

anxiety disorder Depression depressive disorder hearing loss disorder

As listed by the trial registrant

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

Depression Hearing disability Mobility disability

How to take part

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

  1. The places running it

    4 sites. 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

  • Delaware State University

    Dover, Delaware, 19904, United States

  • Louis Stokes Cleveland VAMC

    Cleveland, Ohio, 44016, United States

  • New Jersey Department of Veterans Health

    East Orange, New Jersey, 07018, United States

  • South Texas Veterans Health Care System

    San Antonio, Texas, 78229, United States

More trials for these conditions

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