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Music Therapy for Acute Respiratory Failure

N/A
Recruiting
Led By Joanne Loewy, DA, LCAT, MT-BC
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients with acute hypoxemic respiratory failure, acute hypercapnic respiratory failure, and ARDS admitted to the ICU requiring mechanical ventilation
Patients that are anticipated to remain on invasive mechanical ventilation for 48 hours or more will be screened for participation in the study
Must not have
Cardiac arrest
Coma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at the effects of music therapy on people who are on mechanical ventilation in an ICU.

Who is the study for?
This trial is for adult ICU patients with severe breathing problems who need a machine to help them breathe and are expected to need it for at least 48 hours. It's not for those under 18, with hearing issues, chronic breathing failure history, on multiple strong medications for blood pressure, in a coma, having seizures or cardiac arrest, deeply sedated (RASS score -4 or -5), or nearing end of life.
What is being tested?
The study tests live music therapy tailored to each patient by certified therapists. The therapy includes toning and melodies aimed at syncing with the patient’s vital signs to see if it can reduce the time they spend on mechanical ventilation in the ICU.
What are the potential side effects?
Since this is a non-drug treatment focusing on music therapy provided by professionals trained to adjust interventions according to patient response, significant side effects are not anticipated. However, individual reactions may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am an adult in the ICU needing a ventilator for severe lung issues.
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I expect to be on a breathing machine for at least 48 hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a cardiac arrest.
Select...
I am not in a coma.
Select...
I have a diagnosed hearing disorder.
Select...
I am currently experiencing seizures.
Select...
I am on more than two medications to raise my blood pressure.
Select...
I am younger than 18 years old.
Select...
I have needed a machine to help me breathe due to chronic lung problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Confusion Assessment Method for the ICU (CAM-ICU)
Pain score
Richmond Agitation-Sedation Scale (RASS)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: ToningExperimental Treatment1 Intervention
Vocal Tonal Holding
Group II: SOKExperimental Treatment1 Intervention
Song of kin with lyric content
Group III: ProcessExperimental Treatment1 Intervention
Processing of experience
Group IV: Ocean drum & SOK melodyExperimental Treatment1 Intervention
Ocean drum followed by melody of song of kin
Group V: Holding Harmonic ContainerExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
914 Previous Clinical Trials
572,723 Total Patients Enrolled
John Mondanaro, MA, LCAT, MT-BC, CCLSStudy ChairIcahn School of Medicine at Mount Sinai
Joanne Loewy, DA, LCAT, MT-BCPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Holding Harmonic Container Clinical Trial Eligibility Overview. Trial Name: NCT03642002 — N/A
Acute Respiratory Distress Syndrome Research Study Groups: Toning, Ocean drum & SOK melody, SOK, Process, Holding Harmonic Container
Acute Respiratory Distress Syndrome Clinical Trial 2023: Holding Harmonic Container Highlights & Side Effects. Trial Name: NCT03642002 — N/A
Holding Harmonic Container 2023 Treatment Timeline for Medical Study. Trial Name: NCT03642002 — N/A
~18 spots leftby Sep 2025
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