← Back to Search

Music Therapy for ICU Delirium (DDM Trial)

N/A
Waitlist Available
Led By Babar Khan, MD, MS
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 50 years or older
Admitted to the intensive care unit (medical or surgical)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post hospital discharge
Awards & highlights

DDM Trial Summary

This trial will study whether a seven-day slow-tempo music intervention can decrease delirium/coma free days among mechanically ventilated, critically ill older adults.

Who is the study for?
This trial is for critically ill adults over 50 in the ICU who are expected to need a ventilator for at least 48 hours and can consent through a representative. They must speak English, have phone access, and not have hearing/vision impairments, certain neurological conditions, uncontrolled psychiatric illness, or be at risk of alcohol/drug withdrawal.Check my eligibility
What is being tested?
The study tests if slow-tempo music can reduce delirium/coma days in older adults on mechanical ventilation in the ICU. It's a randomized controlled trial where participants either receive attention control or listen to slow-tempo music daily for seven days.See study design
What are the potential side effects?
Since this intervention involves listening to music, side effects are minimal but may include discomfort from wearing headphones or emotional responses to music. The study excludes those with conditions that could make headphone use unsafe.

DDM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 50 years old or older.
Select...
I am currently in the ICU.

DDM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post hospital discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post hospital discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Days free of delirium and coma
Secondary outcome measures
Anxiety
Cognition
Delirium Severity
+2 more

DDM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Slow Tempo MusicExperimental Treatment1 Intervention
Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.
Group II: Attention ControlPlacebo Group1 Intervention
One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,655 Previous Clinical Trials
28,004,010 Total Patients Enrolled
Indiana UniversityLead Sponsor
976 Previous Clinical Trials
983,217 Total Patients Enrolled
Babar Khan, MD, MS5.01 ReviewsPrincipal Investigator - Indiana University
Indiana University

Media Library

ICU Delirium Research Study Groups: Attention Control, Slow Tempo Music

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have registered to participate in this medical experiment?

"Affirmative. Clinicaltrials.gov displays that this study, which has been available since March 5th 2020, is still actively searching for participants. Currently 160 volunteers must be sourced from five distinct sites."

Answered by AI

Are there still opportunities for enrolment in this clinical experiment?

"According to the clinicaltrials.gov portal, this clinical trial is still open for participation as of October 6th 2022. This research initiative was originally posted on March 5th 2020."

Answered by AI
~32 spots leftby Mar 2025