Decreasing Delirium Through Music in Critically Ill Older Adults

NCT ID: NCT04182334

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-05
• Study Completion Date: 2024-04-08

Brief 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.

Detailed Description

One million adults in the United States receive mechanical ventilation for acute respiratory failure in the intensive care units (ICUs) annually and up to 80% of them develop delirium during their ICU stay. Presence of delirium predisposes older adults to immediate in-hospital complications including a longer length of ICU and hospital stay, increased risk of in-patient mortality and elevated costs of care. In addition, ICU delirium is associated with long-term post-discharge complications such as development of cognitive impairment and dementia.

Recent research studies exploring pharmacological strategies to manage ICU delirium have not demonstrated efficacy; a limitation also acknowledged in the Society of Critical Care Medicine 2018 Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption guidelines. Music listening is a non-pharmacological intervention that has shown to decrease over-sedation, anxiety and stress in critically ill patients, factors that could predispose to ICU delirium. Our team is now proposing to conduct a large randomized clinical trial called "Decreasing Delirium through Music (DDM) in Critically Ill Older Adults to evaluate the efficacy of a seven-day slow-tempo music intervention on the primary outcome of delirium/coma free days among mechanically-ventilated older adults admitted to the ICU.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Slow Tempo Music

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 Type: EXPERIMENTAL

Slow Tempo Music

Intervention Type: OTHER

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

Attention Control

One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.

Group Type: SHAM_COMPARATOR

Attention Control

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 50 years or older.

2. English speaking.

3. Admitted to the intensive care unit (medical or surgical).

4. Expected mechanical ventilator support for ≥48 hours.

5. Consentable through a legally authorized representative.

6. Have access to a telephone.

Exclusion Criteria

1. History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease or vascular dementia.

2. Psychiatric illness which is not well controlled.

3. Alcohol withdrawal symptoms/concern for withdrawal.

4. Suspected or confirmed drug intoxication/overdose

5. Traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery.

6. Uncorrected hearing or vision impairment including legal blindness.

7. Incarcerated at the time of study enrollment.

8. Enrolled in another clinical trial which does not permit co-enrollment.

9. Any medical condition precluding safe use of headphones such as: skin breakdown, burns, facial or skull fractures.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Babar Khan, MD, MS

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Babar Khan, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Linda Chlan, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

IU Health West Hospital

Avon, Indiana, United States

Eskenazi Hospital

Indianapolis, Indiana, United States

IU Health University Hospital

Indianapolis, Indiana, United States

Methodist Hospital

Indianapolis, Indiana, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Countries

United States

References

Khan BA, Khan SH, Perkins AJ, Heiderscheit A, Unverzagt FW, Wang S, Downs JH 3rd, Gao S, Chlan LL. Slow-Tempo Music and Delirium/Coma-Free Days Among Older Adults Undergoing Mechanical Ventilation: A Randomized Clinical Trial. JAMA Intern Med. 2025 Oct 13. doi: 10.1001/jamainternmed.2025.5263. Online ahead of print.

Reference Type: DERIVED

PMID: 41082215 (View on PubMed)

Seyffert S, Moiz S, Coghlan M, Balozian P, Nasser J, Rached EA, Jamil Y, Naqvi K, Rawlings L, Perkins AJ, Gao S, Hunter JD 3rd, Khan S, Heiderscheit A, Chlan LL, Khan B. Decreasing delirium through music listening (DDM) in critically ill, mechanically ventilated older adults in the intensive care unit: a two-arm, parallel-group, randomized clinical trial. Trials. 2022 Jul 19;23(1):576. doi: 10.1186/s13063-022-06448-w.

Reference Type: DERIVED

PMID: 35854358 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R01AG067631-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1906664366

Identifier Type: -

Identifier Source: org_study_id