Clinical trial Recruiting at 3 sites Interventional Ages 18 and up

Effects of music therapy on ICU patients on mechanical ventilation

Official title: The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU

Run by Icahn School of Medicine at Mount Sinai · NCT03642002 · Data updated 2026-11-12

This study is testing if live music therapy can help ICU patients on mechanical ventilation breathe easier and recover faster.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment178 (estimated)
SponsorIcahn School of Medicine at Mount Sinai
Academic / other
Locations3 sites (New York, New York and 2 other locations)
StatusRecruiting
StartedDecember 12, 2018
Main results expectedApril 2027
Study endsDecember 2028
Registry record updatedApril 9, 2025
Trial IDNCT03642002 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adult patients with acute respiratory distress syndrome or acute respiratory failure who are expected to require mechanical ventilation for at least 48 hours.

Probably not a fit

Patients under 18 years of age, those with hearing disorders, or those with severe comorbidities such as active seizures or cardiac arrest may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of live music therapy on adult patients requiring mechanical ventilation in the ICU. It involves 178 patients who will be randomly assigned to either a music therapy group or a control group, with careful matching based on diagnosis, co-morbidities, age, and gender. The music therapy will be tailored to each patient's cultural preferences and will focus on promoting relaxation and comfort through a certified music therapist. The primary goal is to reduce the duration of mechanical ventilation by 35% compared to the control group, while also assessing secondary outcomes such as sedation levels and ICU length of stay.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the duration of mechanical ventilation and improve overall patient comfort and recovery in the ICU.

How similar studies have gone: While music therapy has shown promise in reducing anxiety and pain in various settings, this specific approach of entrained live music therapy in mechanically ventilated ICU patients is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* Under 18 years of age
* Identified hearing disorder
* Prior history of chronic respiratory failure requiring mechanical ventilation
* RASS score of -4, or -5
* Active seizures, or status epilepticus
* Cardiac arrest
* Coma
* End of life
* More than 2 vasopressors

Where it's running

  • Mount Sinai West
    New York, New York, United States
    Recruiting
  • Houston Methodist Hospital
    Houston, Texas, United States
    Recruiting
  • Houston Methodist Research Institute
    Houston, Texas, United States
    Recruiting

Study contacts

  • Principal investigator: Joanne Loewy, DA, LCAT, MT-BC — Icahn School of Medicine at Mount Sinai
  • Study coordinator: Joanne Loewy, DA, LCAT, MT-BC
  • Email: joanne.loewy@mountsinai.org
  • Phone: (212) 420-3484

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.