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Decreasing Delirium Through Music in Critically Ill Older Adults

NCT04182334 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-09-22

Study results available
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Summary

Critically ill older adults admitted to the intensive care unit (ICU) are at a higher risk to develop delirium, which predisposes them to longer lengths of ICU and hospital stay, increased in-patient mortality, and higher risk of new acquired cognitive impairment and dementia. Music listening is a non-pharmacological intervention that holds potential to decrease ICU delirium. The investigators propose a randomized controlled trial to evaluate the efficacy of a seven-day slow-tempo music intervention on the primary outcome of delirium/coma free days among mechanically ventilated, critically ill older adults.

Conditions

  • Intensive Care Unit Delirium
  • Pain
  • Anxiety
  • Intensive Care Acquired Cognitive Impairment

Interventions

OTHER

Slow Tempo Music

For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.

OTHER

Attention Control

Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Indiana University

    lead OTHER

Principal Investigators

  • Babar Khan, MD, MS · Indiana University

  • Linda Chlan, PhD, RN · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-05
Primary Completion
2023-12-15
Completion
2024-04-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04182334 on ClinicalTrials.gov