Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Music therapy device shows promise for PTSD in small pilot study

NCT ID NCT04999852

Symptom relief Sponsor: Indiana University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This pilot study tested the Safe and Sound Protocol (SSP), a device that plays filtered music through an app to stimulate the vagus nerve, in 45 therapy clients with PTSD and anxiety. Participants used the SSP alongside their regular therapy and completed questionnaires about their symptoms before, during, and after the intervention. The goal was to see if the SSP could help reduce PTSD and anxiety symptoms, and to prepare for a larger, more rigorous trial.

What this could mean

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

Active substance
Safe and Sound Protocol (SSP) - a non-invasive device that plays filtered music through an app to stimulate the vagus nerve
What this could lead to
If it works, this could point toward a simple, drug-free way to help people with PTSD and anxiety feel calmer and more regulated.
What could go wrong
This is a very small pilot study with only 45 people, no randomization, and no control group for the SSP. Results may not apply to everyone, and the device is not yet proven effective.

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

45 people

The number who actually took part.

Started

Jul 2021

Finished

Dec 2023

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.

SSP Intervention Arm: Inclusion Criteria: * Client at Spencer Psychology in Bloomington, Indiana * Diagnosed with PTSD or trauma not otherwise specified * Already have agreed with therapist to administer SSP as a part of therapy Exclusion Criteria: * Tinnitus or hearing loss * Diagnosed with cardiac arrhythmia * At high risk for 2019 novel coronavirus (COVID-19) complications based on Center for Disease Control (CDC) guidelines, unless vaccinated Comparison (Treatment As Usual) Arm Additional Criteria: Inclusion Criteria: 1. 18 years of age or older 2. Active psychotherapy client at Spencer Psychology 3. Diagnosis of PTSD or trauma not otherwise specified 4. Match range of PCL-5 baseline scores with treatment arm during screener survey Exclusion criteria: 1. Currently using or have previously used the Safe and Sound Protocol (SSP) in therapy 2. Current therapy includes Eye Movement Desensitization and Reprocessing (EMDR)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Anxiety are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder injury post-traumatic stress disorder

As listed by the trial registrant

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

Anxiety Post-traumatic stress disorder

Contacts and locations

Locations

  • Spencer Psychology

    Bloomington, Indiana, 47403, United States

More trials for these conditions

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